NC TREK™ RX Coronary Dilatation Catheter; NC TREK™ OTW Coronary Dilatation Catheter; TREK™ RX Coronary Dilatation Catheter; TREK™ OTW Coronary Dilatation Catheter; MINI TREK™ RX Coronary Dilatation Catheter; MINI TREK™ OTW Coronary Dilatation Cathete
Catheters, Transluminal Coronary Angioplasty, Percutaneous
Abbott Vascular
The following data is part of a premarket notification filed by Abbott Vascular with the FDA for Nc Trek™ Rx Coronary Dilatation Catheter; Nc Trek™ Otw Coronary Dilatation Catheter; Trek™ Rx Coronary Dilatation Catheter; Trek™ Otw Coronary Dilatation Catheter; Mini Trek™ Rx Coronary Dilatation Catheter; Mini Trek™ Otw Coronary Dilatation Cathete.
Pre-market Notification Details
| Device ID | K180040 |
| 510k Number | K180040 |
| Device Name: | NC TREK™ RX Coronary Dilatation Catheter; NC TREK™ OTW Coronary Dilatation Catheter; TREK™ RX Coronary Dilatation Catheter; TREK™ OTW Coronary Dilatation Catheter; MINI TREK™ RX Coronary Dilatation Catheter; MINI TREK™ OTW Coronary Dilatation Cathete |
| Classification | Catheters, Transluminal Coronary Angioplasty, Percutaneous |
| Applicant | Abbott Vascular 3200 Lakeside Drive Santa Clara, CA 95054 |
| Contact | Emily Zhao |
| Correspondent | Emily Zhao Abbott Vascular 3200 Lakeside Drive Santa Clara, CA 95054 |
| Product Code | LOX |
| CFR Regulation Number | 870.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-01-05 |
| Decision Date | 2018-08-24 |
| Summary: | summary |
Trademark Results [NC TREK]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 NC TREK 77823896 4023287 Live/Registered |
Abbott Cardiovascular Systems Inc. 2009-09-10 |
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