The following data is part of a premarket notification filed by Abiomed Inc. with the FDA for Abiomed 23 Fr Sheath.
| Device ID | K201116 |
| 510k Number | K201116 |
| Device Name: | Abiomed 23 Fr Sheath |
| Classification | Introducer, Catheter |
| Applicant | Abiomed Inc. 22 Cherry Hill Drive Danvers, MA 01923 |
| Contact | Sandy Fowler |
| Correspondent | Sandy Fowler 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 | 2020-04-27 |
| Decision Date | 2020-06-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00813502011791 | K201116 | 000 |
| 00813502011784 | K201116 | 000 |
| 00813502011319 | K201116 | 000 |
| 00813502012910 | K201116 | 000 |