The following data is part of a premarket notification filed by Abbott Vascular with the FDA for Nc Trek Neo Coronary Dilatation Catheter.
| Device ID | K220634 |
| 510k Number | K220634 |
| Device Name: | NC TREK NEO Coronary Dilatation Catheter |
| Classification | Catheters, Transluminal Coronary Angioplasty, Percutaneous |
| Applicant | Abbott Vascular 3200 Lakeside Drive Santa Clara, CA 95054 |
| Contact | Nishi Singh |
| Correspondent | Nishi Singh Abbott Vascular 3200 Lakeside Drive Santa Clara, CA 95054 |
| Product Code | LOX |
| CFR Regulation Number | 870.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-03-04 |
| Decision Date | 2022-06-30 |