The following data is part of a premarket notification filed by Cardiovascular Systems, Inc. with the FDA for Vipercath Xc Peripheral Exchange Catheter.
| Device ID | K211251 |
| 510k Number | K211251 |
| Device Name: | ViperCath XC Peripheral Exchange Catheter |
| Classification | Catheter, Percutaneous |
| Applicant | Cardiovascular Systems, Inc. 1225 Old Hwy 8 NW St. Paul, MN 55112 |
| Contact | Erika Huffman |
| Correspondent | Erika Huffman Cardiovascular Systems, Inc. 1225 Old Hwy 8 NW St. Paul, MN 55112 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-04-26 |
| Decision Date | 2021-05-26 |