510(k) K101615 ยท PDU Catheter For Crossing Total Occlusions
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| Applicant | Baylis Medical Co., Inc., Mississauga, Ontario, CA |
| Decision | Substantially Equivalent, Jul 28, 2010 |
| Received | Jun 9, 2010 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K101615
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.