The following data is part of a premarket notification filed by Abbott Medical with the FDA for Aveir Introducer.
| Device ID | K211989 |
| 510k Number | K211989 |
| Device Name: | Aveir Introducer |
| Classification | Introducer, Catheter |
| 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 | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-28 |
| Decision Date | 2021-07-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05415067034847 | K211989 | 000 |
| 05415067034823 | K211989 | 000 |