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 |