Recognition List Number: 030 Publication Date: 01/15/2013
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 3-111: AAMI / ANSI / ISO 25539-3:2011, Cardiovascular implants - Endovascular devices - Part 3: Vena cava filters. (Cardiovascular)
Date of Standard: 2011. |
| Addresses of Standards Organizations: |
| Association for the Advancement of Medical Instrumentation (AAMI) |
| 4301 North Fairfax Drive |
| Suite 301 |
| Arlington, VA 22203 |
| |
| American National Standards Institute (ANSI) |
| 25 West 43rd Street |
| 4th Floor |
| New York, NY 10036 |
| |
| International Organization for Standardization (ISO)* |
| 1, Rue de Varembe |
| Case Postale 56 |
| CH 1211 Geneva 20, 0 |
|
SWITZERLAND
|
|
| CDRH Office and Division Associated with Recognized Standards: |
| OFFICE OF DEVICE EVALUATION (ODE) | | DIVISION OF CARDIOVASCULAR DEVICES (DCD) |
|
|
| Devices Affected: |
|
| Processes Affected: |
| 510(k), IDE, Design Control Input, Quality System Regulation |
|
| Type of Standard: |
| Vertical, International |
| Extent of Recognition: |
|
| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §870.3375 |
Filter, Intravascular, Cardiovascular |
Class 2 |
DTK |
| |
|
| Relevant Guidance: |
| There is no relevant guidance developed at this time. |
|
| FDA Technical Contact: |
| Nicole Ibrahim |
| FDA/CDRH/ODE |
| 10903 New Hampshire Avenue Building 66, Room 1546 |
| Silver Spring MD 20993 |
| 301/796-5171 |
| Email: nicole.ibrahim@fda.hhs.gov |
|
|
