The following data is part of a premarket notification filed by Abbott with the FDA for Mitraclip G4 Steerable Guide Catheter.
| Device ID | K190167 |
| 510k Number | K190167 |
| Device Name: | MitraClip G4 Steerable Guide Catheter |
| Classification | Catheter, Steerable |
| Applicant | Abbott 3200 Lakeside Drive Santa Clara, CA 95054 |
| Contact | Ekta Lad |
| Correspondent | Ekta Lad Abbott 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 | 2019-01-31 |
| Decision Date | 2019-05-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08717648231025 | K190167 | 000 |