The following data is part of a premarket notification filed by Spectranetics Corp. with the FDA for Clirpath Turbo Plus Excimer Laser Catheters, Models 314-151, 314-159, 317-152, 317-156, 320-006, 320-159, 323-001.
Device ID | K052514 |
510k Number | K052514 |
Device Name: | CLIRPATH TURBO PLUS EXCIMER LASER CATHETERS, MODELS 314-151, 314-159, 317-152, 317-156, 320-006, 320-159, 323-001 |
Classification | Catheter For Crossing Total Occlusions |
Applicant | SPECTRANETICS CORP. 96 TALAMINE CT. Colorado Springs, CO 80907 -5159 |
Contact | Neil Burris |
Correspondent | Neil Burris SPECTRANETICS CORP. 96 TALAMINE CT. Colorado Springs, CO 80907 -5159 |
Product Code | PDU |
CFR Regulation Number | 870.1250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-09-14 |
Decision Date | 2005-10-19 |
Summary: | summary |