510(k) K140775 ยท MCW Catheter, Peripheral, Atherectomy
TURBO-ELITE ATHERECTOMY CATHETERS, TURBO TANDEM SYSTEM
| Applicant | Spectranetics Corporation, Colorado Springs CO, US |
| Decision | Substantially Equivalent, Jul 23, 2014 |
| Received | Mar 28, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K140775
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 28, 2016 | Spectranetics Corporation Turbo Elite Atherectomy Catheter. Models: 410-152, 410-154, 414-151, 414-159, 417-152, 417-156, 420-006, 420-159, 423-001, 423-135-01
The Laser Catheters are used in conjunction with the Spectranetics Terminated |
MCW | None listed |
| Nov 28, 2016 | Spectranetics Corporation ELCA Coronary Atherectomy Catheter. Models: 110-001, 110-002, 110-004, 114-009, 117-016, 117-205, 120-009
The Laser Catheters are used in conjunction with the Spectranetics CVX-300 Excimer Laser Syste Terminated |
LPC | None listed |
| Nov 28, 2016 | Spectranetics Corporation Bridge Occlusion Balloon. Model: 590-001
Temporary vessel occlusion of the superior vena cava in applications including perioperative occlusion and emergency control of hemorrhage. Any use for procedu Terminated |
MJN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.