The following data is part of a premarket notification filed by Spectranetics, Inc. with the FDA for Turbo-power (2.0mm) Laser Atherectomy Catheters.
| Device ID | K162561 |
| 510k Number | K162561 |
| Device Name: | Turbo-Power (2.0mm) Laser Atherectomy Catheters |
| 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 | 2016-09-14 |
| Decision Date | 2017-01-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00813132024833 | K162561 | 000 |