The following data is part of a premarket notification filed by Bard Peripheral Vascular, Inc. with the FDA for Bard Atlas Pta Balloon Dilatation Catheter.
| Device ID | K052236 |
| 510k Number | K052236 |
| Device Name: | BARD ATLAS PTA BALLOON DILATATION CATHETER |
| Classification | Catheter, Percutaneous |
| Applicant | BARD PERIPHERAL VASCULAR, INC. 1415 WEST 3RD ST. Tempe, AZ 85281 |
| Contact | Genevieve Balutowski |
| Correspondent | Genevieve Balutowski BARD PERIPHERAL VASCULAR, INC. 1415 WEST 3RD ST. Tempe, AZ 85281 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-08-17 |
| Decision Date | 2005-08-23 |
| Summary: | summary |