The following data is part of a premarket notification filed by Spectranetics Corp. with the FDA for Clirpath Excimer Laser Catheter.
| Device ID | K040067 |
| 510k Number | K040067 |
| Device Name: | CLIRPATH EXCIMER LASER CATHETER |
| Classification | Catheter For Crossing Total Occlusions |
| Applicant | SPECTRANETICS CORP. 96 TALAMINE CT. Colorado Springs, CO 80907 -5159 |
| Contact | Adrian Elfe |
| Correspondent | Adrian Elfe 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 | 2004-01-14 |
| Decision Date | 2004-04-27 |
| Summary: | summary |