510(k) K071227 ยท PDU Catheter For Crossing Total Occlusions
CLIRPATH TURBO EXCIMER LASER CATHETER (RX) -0.9MM, (RX) -1.4MM, (RX) -1.7MM, (RX) -2.0MM, MODEL 310-154, 314-159, 317-15
| Applicant | Spectranetics Corp., Colorado Springs CO, US |
| Decision | Substantially Equivalent, Jul 11, 2007 |
| Received | May 3, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K071227
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 11, 2009 | Spectranetics Corporation Turbo Elite 0.9mm Turbo Elite (TE) RX, Model #410-154, tip diameter 0.9mm/.038 in, 4 Fr, sterile EO. Manufactured by Spectranetics, 96 Talamine Court, Colorado Springs, CO 80907.
The pouch label of Terminated |
MJQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.