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- Jawz Endomyocardial Biopsy Forceps DE Certificate
Jawz Endomyocardial Biopsy Forceps DE Certificate
Jawz Endomyocardial Biopsy Forceps DE Certificate
This document is an EC Design-Examination Certificate issued to Argon Medical Devices, Inc. for their Endomyocardial Biopsy Forceps. The certificate, first issued on February 28, 2011, is valid until May 26, 2024, provided the quality system is maintained according to Directive 93/42/EEC on Medical Devices, Annex II Section 4.
Product Specifications
The certificate covers various models of JAWZ Endomyocardial Biopsy Forceps, each designed for specific medical procedures such as Right Ventricular Biopsies using the Jugular Approach and Right or Left Ventricular Pediatric Biopsies using the Femoral Approach. All models are classified as Class III medical devices.
Device Models
- 190020: 7.5F Straight, 2.4mm x 50cm, Non-fenestrated Jaw, Stainless Steel
- 190030: 7.5F Pre-Curve, 2.4mm x 50cm, Non-Fenestrated Jaw, FEP Coated
- 190031: 7.5F Maxi-Curve, 2.4mm x 50cm, Non-Fenestrated Jaw, FEP Coated
- 190040: 7.5F Straight, 2.4mm x 105cm, Non-Fenestrated Jaw, Stainless Steel
- 190051: 6F Maxi-Curve, 1.8mm x 50cm, Non-Fenestrated Jaw, FEP Coated
- 190060: 6F Straight, 1.8mm x 50cm, Non-Fenestrated Jaw, Stainless Steel
- 190065: 6F Straight, 1.8mm x 50cm, Non-Fenestrated Jaw, Non-Formable Stainless Steel
- 190066: 6F Straight, 1.8mm x 70cm, Non-Fenestrated Jaw, FEP Coated
- 190070: 6F Straight, 1.8mm x 105cm, Non-Fenestrated Jaw, Stainless Steel
- 190075: 6F Straight, 1.8mm x 105cm, Non-Fenestrated Jaw, Non-Formable Stainless Steel
- 190080: 7F Pre-curve, 2.2mm x 50cm, Non-Fenestrated Jaw, FEP Coated
- 190081: 7F Maxi-Curve, 2.2mm x 50cm, Non-Fenestrated Jaw, FEP Coated
- 190085: 7F Straight, 2.2mm x 105cm, Non-Fenestrated Jaw, Stainless Steel
- 190086: 7F Straight, 2.2mm x 105cm, Non-Fenestrated Jaw, FEP Coated
- 190090: 5F Straight, 1.5mm x 50cm, Fenestrated Jaw, Stainless Steel
- 190095: 5F Straight, 1.5mm x 105cm, Fenestrated Jaw, Stainless Steel
Certificate History
The certificate has undergone several renewals and updates, including the addition of a sterilization location and the removal of a product code. The most recent renewal included the addition of a device table.
Contact Information
For further information, contact BSI Group The Netherlands B.V., located at John M. Keynesplein 9, 1066 EP Amsterdam, The Netherlands.
Catalog excerpts
EC Design-Examination Certificate Directive 93/42/EEC on Medical Devices, Annex II Section 4 Supplementary Information to CE 565720 Issued To: No. Issued To: Argon Medical Devices, Inc. CE 565720 1445 Flat Creek Road Argon Medical Devices, Inc. Athens 1445 Flat Texas Creek Road 75751 Athens USA Texas Endomyocardial Biopsy Forceps BSI has performed a design examination on the above devices in accordance with the Council Directive 93/42/EEC, Annex II Section 4. The design conforms to the requirements of this directive. For marketing of these products an additional Annex II excluding Section 4 certificate is required. For and on behalf of BSI, a Notified Body for the above Directive (Notified Body Number 2797): Gary E Slack, Senior Vice President Medical Devices First First Issued: Issued: 2011-02-28 2011-02-28 Expiry Expiry Date: Date: 2024-05-26 2024-05-26 Page 1 of 6 Validity of this certificate is conditional on the quality system being maintained to the requirements of the Directive as demonstrated through the required surveillance activities of the Notified Body. This certificate was issued electronically and is bound by the conditions of the contract. Information and Contact: BSI, Say Building, John M. Keynesplein 9, 1066 EP Amsterdam, The Netherlands Tel: + 31 20 346 0780 BSI Group The Netherlands B.V. registered in The Netherlands under 33264284. A member of BSI Group of Companies.
Open the catalog to page 1
Issued To: Argon Medical Devices, Inc. 1445 Flat Creek Road First Issued: 2011-02-28 Date: 2020-04-15 Expiry Date: 2024-05-26 Validity of this certificate is conditional on the quality system being maintained to the requirements of the Directive as demonstrated through the required surveillance activities of the Notified Body. This certificate was issued electronically and is bound by the conditions of the contract. Information and Contact: BSI, Say Building, John M. Keynesplein 9, 1066 EP Amsterdam, The Netherlands Tel: + 31 20 346 0780 BSI Group The Netherlands B.V. registered in The Netherlands...
Open the catalog to page 2
1445 Flat Creek Road First Issued: 2011-02-28 Date: 2020-04-15 Expiry Date: 2024-05-26 Validity of this certificate is conditional on the quality system being maintained to the requirements of the Directive as demonstrated through the required surveillance activities of the Notified Body. This certificate was issued electronically and is bound by the conditions of the contract. Information and Contact: BSI, Say Building, John M. Keynesplein 9, 1066 EP Amsterdam, The Netherlands Tel: + 31 20 346 0780 BSI Group The Netherlands B.V. registered in The Netherlands under 33264284. A member of BSI Group...
Open the catalog to page 3
1445 Flat Creek Road First Issued: 2011-02-28 Date: 2020-04-15 Expiry Date: 2024-05-26 Validity of this certificate is conditional on the quality system being maintained to the requirements of the Directive as demonstrated through the required surveillance activities of the Notified Body. This certificate was issued electronically and is bound by the conditions of the contract. Information and Contact: BSI, Say Building, John M. Keynesplein 9, 1066 EP Amsterdam, The Netherlands Tel: + 31 20 346 0780 BSI Group The Netherlands B.V. registered in The Netherlands under 33264284. A member of BSI Group...
Open the catalog to page 4
1445 Flat Creek Road First Issued: 2011-02-28 Date: 2020-04-15 Expiry Date: 2024-05-26 Validity of this certificate is conditional on the quality system being maintained to the requirements of the Directive as demonstrated through the required surveillance activities of the Notified Body. This certificate was issued electronically and is bound by the conditions of the contract. Information and Contact: BSI, Say Building, John M. Keynesplein 9, 1066 EP Amsterdam, The Netherlands Tel: + 31 20 346 0780 BSI Group The Netherlands B.V. registered in The Netherlands under 33264284. A member of BSI Group...
Open the catalog to page 5
bsi.EC Design-Examination Certificate Supplementary Information to CE 565720 Issued To: Argon Medical Devices, Inc. 1445 Flat Creek Road First Issued: 2011-02-28 Date: 2020-04-15 Expiry Date: 2024-05-26 ...making excellence a habit!" Page 6 of 6 Validity of this certificate is conditional on the quality system being maintained to the requirements of the Directive as demonstrated through the required surveillance activities of the Notified Body. This certificate was issued electronically and is bound by the conditions of the contract. Information and Contact: BSI, Say Building, John M. Keynesplein...
Open the catalog to page 6
