510(k) K011727 ยท DRC Trocar
TRANSSEPTAL NEEDLE/TROCAR
| Applicant | Thomas Medical Products, Inc., Malvern PA, US |
| Decision | Substantially Equivalent, May 2, 2002 |
| Received | Jun 4, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K011727
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 15, 2016 | Merit Medical Systems, Inc. Boston Scientific TSX Transseptal Needle, Model Number M004TSX60o;
Used to create the primary puncture in the interatrial septum when passing an intruder and/or catheter through the septum from the ri Terminated |
DRC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.