Recognition List Number: 026 Publication Date: 03/18/2011
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 3-90: ISO 7198 First edition 1998-08-01, Cardiovascular implants - Tubular vascular prostheses. (Cardiovascular)
Date of Standard: 1998. |
| Address of Standards Organization: |
| International Organization for Standardization (ISO)* |
| 1, Rue de Varembe |
| Case Postale 56 |
| CH 1211 Geneva 20, 0 |
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SWITZERLAND
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| CDRH Office and Division Associated with Recognized Standards: |
| OFFICE OF DEVICE EVALUATION (ODE) | | DIVISION OF CARDIOVASCULAR DEVICES (DCD) |
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| Devices Affected: |
| Vascular Graft Prostheses |
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| Processes Affected: |
| 510(k), PMA, IDE, PDP, Design Control Input, Quality System Regulation |
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| Type of Standard: |
| Vertical |
| Extent of Recognition: |
Complete standard
NOTE: This standard identifies critical parameters for the various types of vascular prostheses and prescribes test methods. It does not contain acceptance criteria for the parameters. Additional information as outlined in the Guidance referenced below must be provided. |
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| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §870.3450 |
Prosthesis, Vascular Graft, Of 6mm And Greater Diameter |
Class 2 |
DSY |
| §870.3450 |
Prosthesis, Vascular Graft, Of Less Then 6mm Diameter |
Class 2 |
DYF |
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| Relevant Guidance: |
Special Controls for Vascular Prostheses
Draft Guidance for the Preparation of Research and Marketing Applications for Vascular Graft Protheses (NOTE: The FDA document predates the AAMI standard. Information covered by AAMI Standard supersedes the FDA document) |
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| FDA Technical Contact: |
| Dorothy Abel |
| FDA/CDRH/ODE |
| 10903 New Hampshire Avenue Building 66, Room 1204 |
| Silver Spring MD 20993 |
| 301/796-6366 |
| Email: dorothy.abel@fda.hhs.gov |
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