510(k) K071226 ยท PDU Catheter For Crossing Total Occlusions
8FR TURBO BOOSTER, GUIDE CATHETER, 7FR TURBO BOOSTER, MODEL 518-063, 518-043
| Applicant | Spectranetics Corp., Colorado Springs CO, US |
| Decision | Substantially Equivalent, Jun 29, 2007 |
| Received | May 3, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K071226
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 4, 2011 | Spectranetics Corporation Spectranetics Turbo-Booster Laser Guide Catheter, 7 Fr, REF 518-043, Sterile EO, Spectranetics Corporation, 96 Talamine Court, Colorado Springs, CO 80907.
Designed for directing and supporting Spectr Terminated |
DQY | None listed |
| Aug 4, 2011 | Spectranetics Corporation Spectranetics Turbo-Booster Laser Guide Catheter, 8 Fr, REF 518-063, Sterile EO, Spectranetics Corporation, 96 Talamine Court, Colorado Springs, CO 80907.
Designed for directing and supporting Spectr Terminated |
DQY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.