The following data is part of a premarket notification filed by Abbott Vascular-cardiac Therapies with the FDA for Voyager Nc Coronary Dilatation Catheter And Nc Trek Rx Coronary Dilatation Catheter.
| Device ID | K103153 |
| 510k Number | K103153 |
| Device Name: | VOYAGER NC CORONARY DILATATION CATHETER AND NC TREK RX CORONARY 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 | 2010-10-14 |
| Decision Date | 2010-12-30 |
| Summary: | summary |