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 | K180694 |
510k Number | K180694 |
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 | Travis Pittman |
Correspondent | Travis Pittman 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 | 2018-03-16 |
Decision Date | 2018-04-05 |
Summary: | summary |