510(k) K102948 ยท DYB Introducer, Catheter
TORFLEX TRANSSEPTAL GUIDING SHEATH
| Applicant | Baylis Medical Co., Inc., Mississauga, Ontario, CA |
| Decision | Substantially Equivalent, Apr 1, 2011 |
| Received | Oct 5, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K102948
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 21, 2020 | Baylis Medical Company Inc. TorFlex Transseptal Guiding Sheath ; Model numbers: TF8-32-63-45, TF8-32-63-55, TF8-32-63-90, TF8-32-63-135, TF85-32-63-37, TF85-32-63-45, TF85-32-63-55, TF85-32-63-90, TF85-32-63-135, TF8-32-81-45, T Terminated |
DYB | None listed |
| May 21, 2020 | Baylis Medical Company Inc. NRG RF Transseptal Kit; Model No.s : NTK-710-8545, NTK-710-8555, NTK-711-8545, NTK-711-8555, NTK-711-8590, NTK-P711-8545, NTK-P711-8555, NTK-710-8545S, NTK-710-8555S, NTK-711-8545S, NTK-711-8555S, NTK Terminated |
DYB | None listed |
| Nov 1, 2013 | Baylis Medical Corp * Baylis Medical TorFlex Transseptal Guiding Sheath, Rx Only, non-pyrogenic, sterile.
Product Usage: The TorFlex Transseptal Guiding Sheath kit (K102948) is a single use device consisting of three com Terminated |
DYB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.