The following data is part of a premarket notification filed by Abbott Vascular with the FDA for Viatrac 14 Plus Peripheral Dilatation Catheter.
| Device ID | K221057 |
| 510k Number | K221057 |
| Device Name: | Viatrac 14 Plus Peripheral Dilatation Catheter |
| Classification | Catheter, Angioplasty, Peripheral, Transluminal |
| Applicant | Abbott Vascular 3200 Lakeside Drive Santa Clara, CA 95054 |
| Contact | Jiyoung Dang |
| Correspondent | Jiyoung Dang Abbott Vascular 3200 Lakeside Drive Santa Clara, CA 95054 |
| Product Code | LIT |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-04-11 |
| Decision Date | 2022-05-05 |