The following data is part of a premarket notification filed by Spectranetics Corp. with the FDA for Spectranetics Turbo-tandem System.
| Device ID | K091299 |
| 510k Number | K091299 |
| Device Name: | SPECTRANETICS TURBO-TANDEM SYSTEM |
| Classification | Catheter, Percutaneous |
| Applicant | SPECTRANETICS CORP. 9965 Federal Drive Colorado Springs, CO 80921 |
| Contact | Gracie Murguia |
| Correspondent | Gracie Murguia SPECTRANETICS CORP. 9965 Federal Drive Colorado Springs, CO 80921 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-05-04 |
| Decision Date | 2009-07-01 |
| Summary: | summary |