The following data is part of a premarket notification filed by Abbott Medical with the FDA for Aveir Retrieval Catheter.
| Device ID | K213494 |
| 510k Number | K213494 |
| Device Name: | Aveir Retrieval Catheter |
| Classification | Device, Percutaneous Retrieval |
| Applicant | Abbott Medical 15900 Valley View Court Sylmar, CA 91342 |
| Contact | Bijal Jain |
| Correspondent | Bijal Jain Abbott Medical 15900 Valley View Court Sylmar, CA 91342 |
| Product Code | MMX |
| CFR Regulation Number | 870.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-11-01 |
| Decision Date | 2022-04-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05415067034496 | K213494 | 000 |