The following data is part of a premarket notification filed by Spectranetics, Inc. with the FDA for Turbo-power Laser Atherectomy Catheter.
| Device ID | K152181 |
| 510k Number | K152181 |
| Device Name: | Turbo-Power Laser Atherectomy Catheter |
| Classification | Catheter, Peripheral, Atherectomy |
| Applicant | SPECTRANETICS, INC. 9965 FEDERAL DRIVE Colorado Springs, CO 80921 |
| Contact | Priscila Tapia |
| Correspondent | Priscila Tapia SPECTRANETICS, INC. 9965 FEDERAL DRIVE Colorado Springs, CO 80921 |
| Product Code | MCW |
| CFR Regulation Number | 870.4875 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-08-04 |
| Decision Date | 2015-11-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00813132022983 | K152181 | 000 |