The following data is part of a premarket notification filed by Spectranetics Corp. with the FDA for Clirpath Turbo Excimer Laser Catheter (rx) -0.9mm, (rx) -1.4mm, (rx) -1.7mm, (rx) -2.0mm, Model 310-154, 314-159, 317-15.
| Device ID | K071227 |
| 510k Number | K071227 |
| Device Name: | CLIRPATH TURBO EXCIMER LASER CATHETER (RX) -0.9MM, (RX) -1.4MM, (RX) -1.7MM, (RX) -2.0MM, MODEL 310-154, 314-159, 317-15 |
| Classification | Catheter For Crossing Total Occlusions |
| Applicant | SPECTRANETICS CORP. 96 TALAMINE CT. Colorado Springs, CO 80907 -5159 |
| Contact | Michael K Handley |
| Correspondent | Michael K Handley 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 | 2007-05-03 |
| Decision Date | 2007-07-11 |
| Summary: | summary |