510(k) K073326 ยท DXF Catheter, Septostomy
NRG TRANSSEPTAL NEEDLE
| Applicant | Baylis Medical Co., Inc., Mississauga, Ontario, CA |
| Decision | Substantially Equivalent, May 28, 2008 |
| Received | Nov 27, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K073326
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 10, 2016 | Baylis Medical Corp * NRG Transseptal Needle and NRG RF Transseptal Kit.
Model/Catalogue Numbers: NRG-56-32-C0, NRG-71-C0, NRG-71-C1, NRG-89-C0, NRG-89-C1, NRG-98-C0, NRG-98-C1, NRG-98-C1-T, NRG-E-56-32-C0, and NRG-E-HF- Terminated |
DXF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.