The following data is part of a premarket notification filed by Abiomed Inc. with the FDA for Abiomed 14fr Low Profile Introducer Set.
| Device ID | K222113 |
| 510k Number | K222113 |
| Device Name: | Abiomed 14Fr Low Profile Introducer Set |
| Classification | Introducer, Catheter |
| Applicant | Abiomed Inc. 22 Cherry Hill Drive Danvers, MA 01923 |
| Contact | Ken Ryder |
| Correspondent | Ken Ryder Abiomed Inc. 22 Cherry Hill Drive Danvers, MA 01923 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-07-18 |
| Decision Date | 2022-10-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00813502013252 | K222113 | 000 |
| 00813502012996 | K222113 | 000 |
| 00813502013474 | K222113 | 000 |
| 00813502012736 | K222113 | 000 |
| 00813502012729 | K222113 | 000 |
| 00813502013269 | K222113 | 000 |