The following data is part of a premarket notification filed by C. R. Bard, Inc. with the FDA for Vascutrak Pta Dilatation Catheter.
| Device ID | K103459 |
| 510k Number | K103459 |
| Device Name: | VASCUTRAK PTA DILATATION CATHETER |
| Classification | Catheter, Percutaneous, Cutting/scoring |
| Applicant | C. R. BARD, INC. 1625 W 3RD STREET Tempe, AZ 85281 |
| Contact | Candace Wade |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | PNO |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2010-11-24 |
| Decision Date | 2010-12-13 |
| Summary: | summary |