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 | K183000 |
| 510k Number | K183000 |
| Device Name: | ViperCath XC Peripheral Exchange Catheter |
| Classification | Catheter, Percutaneous |
| Applicant | Cardiovascular Systems, Inc. 1225 Old Highway 8 NW St. Paul, MN 55112 |
| Contact | Erika Huffman |
| Correspondent | Erika Huffman Cardiovascular Systems, Inc. 1225 Old Highway 8 NW St. Paul, MN 55112 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-10-30 |
| Decision Date | 2018-12-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10852528005695 | K183000 | 000 |
| 10852528005688 | K183000 | 000 |