510(k) K014075 ยท DQX Wire, Guide, Catheter
BMC COAXIAL INJECTABLE CATHETER, MODEL CIC 38/145 AND CIC 35/145
| Applicant | Baylis Medical Co., Inc., Mississauga, Ontario, CA |
| Decision | Substantially Equivalent, Mar 7, 2002 |
| Received | Dec 11, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K014075
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 1, 2015 | Baylis Medical Corp * ProTrack Microcatheter. Model/Catalog Numbers CIC38-145, CIC35-145. Sterile, single use device intended to be used as a standard infusion wire or as an exchange guide for exchanging guidewires. Coa Terminated |
DQX | None listed |
| Apr 13, 2015 | Baylis Medical Corp * ProTrack Microcatheter;
Product Usage: The ProTrack Microcatheter is a sterile, single use device intended to be used as a standard infusion wire or as an exchange guide for exchanging guidewires. Terminated |
DQX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.