The following data is part of a premarket notification filed by Bard Peripheral Vacular, Inc. with the FDA for Crosser Cto Recanalization Catheter.
| Device ID | K161208 |
| 510k Number | K161208 |
| Device Name: | CROSSER CTO Recanalization Catheter |
| Classification | Catheter For Crossing Total Occlusions |
| Applicant | Bard Peripheral Vacular, Inc. 1625 West 3rd Street Tempe, AZ 85281 |
| Contact | Melanie Hadlock |
| Correspondent | Melanie Hadlock Bard Peripheral Vacular, Inc. 1625 West 3rd Street Tempe, AZ 85281 |
| Product Code | PDU |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-28 |
| Decision Date | 2016-05-24 |
| Summary: | summary |