The following data is part of a premarket notification filed by Spectranetics Corp. with the FDA for 8fr Turbo - Tandem System.
| Device ID | K112032 |
| 510k Number | K112032 |
| Device Name: | 8FR TURBO - TANDEM SYSTEM |
| Classification | Catheter, Percutaneous |
| Applicant | SPECTRANETICS CORP. 9965 FEDERAL DR. Colorado Springs, CO 80921 |
| Contact | Shelley Wilcox |
| Correspondent | Shelley Wilcox SPECTRANETICS CORP. 9965 FEDERAL DR. 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 | 2011-07-15 |
| Decision Date | 2011-10-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M204482110AA0 | K112032 | 000 |
| M2044821100 | K112032 | 000 |