The following data is part of a premarket notification filed by Spectranetics Corp. with the FDA for 2.5 Mm Turbo Clirpath Excimer Laser Catheter, Model 225-011.
| Device ID | K043465 |
| 510k Number | K043465 |
| Device Name: | 2.5 MM TURBO CLIRPATH EXCIMER LASER CATHETER, MODEL 225-011 |
| Classification | Catheter For Crossing Total Occlusions |
| Applicant | SPECTRANETICS CORP. 96 TALAMINE CT. Colorado Springs, CO 80907 -5159 |
| Contact | Adrian E Elfe |
| Correspondent | Adrian E 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 | 2004-12-15 |
| Decision Date | 2005-08-18 |
| Summary: | summary |