The following data is part of a premarket notification filed by Cardiovascular Systems, Inc. with the FDA for Vipercross Support Catheters.
| Device ID | K211240 |
| 510k Number | K211240 |
| Device Name: | ViperCross Support Catheters |
| Classification | Catheter, Percutaneous |
| Applicant | Cardiovascular Systems, Inc. 1225 Old Highway 8 NW Saint Paul, MN 55112 |
| Contact | Erika Huffman |
| Correspondent | Jonathan Holmes Cardiovascular Systems, Inc. 6030 W. Harold Gatty Dr. Salt Lake City, UT 84116 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-04-26 |
| Decision Date | 2021-08-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10850026568247 | K211240 | 000 |
| 10850026568230 | K211240 | 000 |
| 10850026568209 | K211240 | 000 |
| 10850026568193 | K211240 | 000 |
| 10850026568162 | K211240 | 000 |
| 10850026568131 | K211240 | 000 |
| 10850026568124 | K211240 | 000 |