The following data is part of a premarket notification filed by Spectranetics Inc. with the FDA for Turbo-power (2.0mm) Laser Atherectomy Catheters, Turbo-power (2.3mm) Laser Atherectomy Catheters.
| Device ID | K222837 |
| 510k Number | K222837 |
| Device Name: | Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters |
| Classification | Catheter, Peripheral, Atherectomy |
| Applicant | Spectranetics Inc. 9965 Federal Drive Colorado Springs, CO 80921 |
| Contact | Taylor Olen |
| Correspondent | Taylor Olen Spectranetics Inc. 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 | 2022-09-20 |
| Decision Date | 2022-12-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00813132029951 | K222837 | 000 |
| 00813132029944 | K222837 | 000 |