The following data is part of a premarket notification filed by Spectranetics Corp. with the FDA for Turbo-tandem System Model 472-110.
| Device ID | K094036 |
| 510k Number | K094036 |
| Device Name: | TURBO-TANDEM SYSTEM MODEL 472-110 |
| Classification | Catheter, Peripheral, Atherectomy |
| Applicant | SPECTRANETICS CORP. 9965 Federal Drive Colorado Springs, CO 80921 |
| Contact | Michael K Handley |
| Correspondent | Michael K Handley SPECTRANETICS CORP. 9965 Federal Drive Colorado Springs, CO 80921 |
| Product Code | MCW |
| CFR Regulation Number | 870.4875 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-12-30 |
| Decision Date | 2010-01-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M204472110AA0 | K094036 | 000 |
| M2044721100 | K094036 | 000 |