The following data is part of a premarket notification filed by Abbott Vascular with the FDA for Mini Trek Rx 1.20 Mm Coronary Dilatation Catheter, Mini Trek Otw 1.20 Mm Coronary Dilatation Catheter.
| Device ID | K110617 |
| 510k Number | K110617 |
| Device Name: | MINI TREK RX 1.20 MM CORONARY DILATATION CATHETER, MINI TREK OTW 1.20 MM CORONARY DILATATION CATHETER |
| Classification | Catheters, Transluminal Coronary Angioplasty, Percutaneous |
| Applicant | Abbott Vascular 26531 YNEZ ROAD Temecula, CA 92591 |
| Contact | Suzanne Redman |
| Correspondent | Suzanne Redman Abbott Vascular 26531 YNEZ ROAD Temecula, CA 92591 |
| Product Code | LOX |
| CFR Regulation Number | 870.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-03-03 |
| Decision Date | 2011-06-02 |
| Summary: | summary |