The following data is part of a premarket notification filed by Cardiovascular Systems, Inc. with the FDA for Vipersphere Pta Balloon Catheter.
| Device ID | K083139 |
| 510k Number | K083139 |
| Device Name: | VIPERSPHERE PTA BALLOON CATHETER |
| Classification | Catheter, Percutaneous |
| Applicant | CARDIOVASCULAR SYSTEMS, INC. 651 CAMPUS DR. St. Paul, MN 55112 |
| Contact | David Brooke |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2008-10-23 |
| Decision Date | 2008-11-25 |
| Summary: | summary |