510(k) K050916 ยท PDU Catheter For Crossing Total Occlusions
SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM [PERIPHERAL]
| Applicant | Intra Luminal Therapeutics, Inc., Carlsbad CA, US |
| Decision | Substantially Equivalent, Jun 8, 2005 |
| Received | Apr 12, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K050916
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.