The following data is part of a premarket notification filed by Abbott Medical with the FDA for Mitraclip G4 Steerable Guide Catheter.
| Device ID | K221397 |
| 510k Number | K221397 |
| Device Name: | MitraClip G4 Steerable Guide Catheter |
| Classification | Catheter, Steerable |
| Applicant | Abbott Medical 177 Country Road B East Saint Paul, MN 55117 |
| Contact | Cynthia Aguirre |
| Correspondent | Irma Barr Abbott Medical 3200 Lakeside Drive Santa Clara, CA 95054 |
| Product Code | DRA |
| CFR Regulation Number | 870.1280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-05-13 |
| Decision Date | 2022-09-28 |