510(k) K013919 ยท DBY Fab, Rhodamine, Antigen, Antiserum, Control
TORFLEX TRANSSEPTAL GUIDING SHEATH
| Applicant | Baylis Medical Co., Inc., Mississauga, Ontario, CA |
| Decision | Substantially Equivalent, Feb 22, 2002 |
| Received | Nov 27, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K013919
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 10, 2010 | Baylis Medical Corp * Torflex Transseptal Guiding Sheath, Baylis Medical Company Inc., 5959 Trans-Canada Highway, Montreal, QC, Canada H4T1A1, (514) 488-9802; INCLUDES: One (1) Radiopaque Sheath, One (1) Radiopaque Dilator Terminated |
DYB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.