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Atrieve Vascular Snare Kit CE Certificate
Atrieve Vascular Snare Kit CE Certificate
This document is an EC Design-Examination Certificate issued to Argon Medical Devices, Inc. for the Atrieve™ Vascular Snare Kit. It confirms that the design of the product conforms to the requirements of the Council Directive 93/42/EEC on Medical Devices, Annex II Section 4. The certificate was first issued on February 28, 2014, and is valid until February 27, 2024, provided that the quality system is maintained as per the directive's requirements.
Product Specifications:
The Atrieve™ Vascular Snare Kit is available in various configurations, each with specific dimensions and characteristics:
- Product Code 381003004: Diameter 4 mm, Working Diameter 2-4 mm, Snare Length 175 cm, Shaft Diameter 0.018 in, Delivery Catheter Size 3.2 Fr, Length 150 cm, Inside Diameter 0.030 in.
- Product Code 381003008: Diameter 8 mm, Working Diameter 4-8 mm, Snare Length 175 cm, Shaft Diameter 0.018 in, Delivery Catheter Size 3.2 Fr, Length 150 cm, Inside Diameter 0.030 in.
- Product Code 382006010: Diameter 10 mm, Working Diameter 6-10 mm, Snare Length 120 cm, Shaft Diameter 0.026 in, Delivery Catheter Size 6 Fr, Length 100 cm, Inside Diameter 0.062 in.
- Product Code 382006015: Diameter 15 mm, Working Diameter 9-15 mm, Snare Length 120 cm, Shaft Diameter 0.026 in, Delivery Catheter Size 6 Fr, Length 100 cm, Inside Diameter 0.062 in.
- Product Code 382006020: Diameter 20 mm, Working Diameter 12-20 mm, Snare Length 120 cm, Shaft Diameter 0.026 in, Delivery Catheter Size 6 Fr, Length 100 cm, Inside Diameter 0.062 in.
- Product Code 382007030: Diameter 30 mm, Working Diameter 18-30 mm, Snare Length 120 cm, Shaft Diameter 0.026 in, Delivery Catheter Size 7 Fr, Length 100 cm, Inside Diameter 0.074 in.
- Product Code 382007045: Diameter 45 mm, Working Diameter 27-45 mm, Snare Length 120 cm, Shaft Diameter 0.026 in, Delivery Catheter Size 7 Fr, Length 100 cm, Inside Diameter 0.074 in.
Certificate History:
- February 28, 2014: First issue of the certificate.
- June 8, 2018: Removal of reference to Becton Dickinson Infusion Therapy Systems Inc. from the certificate address.
- February 19, 2019: Traceable to NB 0086.
- Current: Certificate renewal under reference number 9665677.
Contact Information:
For further information, contact BSI at their Amsterdam office. The certificate is issued by BSI Group The Netherlands B.V., a member of BSI Group of Companies.
Catalog excerpts
EC Design-Examination Certificate Directive 93/42/EEC on Medical Devices, Annex II Section 4 Supplementary Information to CE 608298 Issued To: No. Issued To: Argon Medical Devices, Inc. CE 608298 1445 Flat Creek Road Argon Medical Devices, Inc. Athens 1445 Flat Texas Creek Road 75751 Athens USA Texas Atrieve™ Vascular Snare Kit 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: 2014-02-28 2014-02-28 Expiry Expiry Date: Date: 2024-02-27 2024-02-27 Page 1 of 3 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.
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bsi.EC Design-Examination CertificateSupplementary Information to CE 608298Issued To: Argon Medical Devices, Inc. 1445 Flat Creek Road USA Product: Atrieve™ Vascular Snare Kit First Issued: 2014-02-28 Date: 2019-06-27 Expiry Date: 2024-02-27 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 2
Issued To: Argon Medical Devices, Inc. 1445 Flat Creek Road First Issued: 2014-02-28 Date: 2019-06-27 Expiry Date: 2024-02-27 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 3
