The following data is part of a premarket notification filed by Abbott Vascular-cardiac Therapies with the FDA for Mini Trek(tm) Rx And Trek(tm) Rx Coronary Dilatation Catheter Mini Trek(tm) Otw And Trek(tm) Otw Dilatation Catheter.
| Device ID | K103110 |
| 510k Number | K103110 |
| Device Name: | MINI TREK(TM) RX AND TREK(TM) RX CORONARY DILATATION CATHETER MINI TREK(TM) OTW AND TREK(TM) OTW DILATATION CATHETER |
| Classification | Catheters, Transluminal Coronary Angioplasty, Percutaneous |
| Applicant | ABBOTT VASCULAR-CARDIAC THERAPIES 26531 YNEZ RD. MAILING P.O. BOX 9018 Temecula, CA 92589 -9018 |
| Contact | Suzanne Redman |
| Correspondent | Suzanne Redman ABBOTT VASCULAR-CARDIAC THERAPIES 26531 YNEZ RD. MAILING P.O. BOX 9018 Temecula, CA 92589 -9018 |
| Product Code | LOX |
| CFR Regulation Number | 870.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-10-08 |
| Decision Date | 2011-01-10 |
| Summary: | summary |