510(k) K040713 ยท DYB Introducer, Catheter
MODIFICATION TO BRAIDED GUIDING INTRODUCER SYSTEM
| Applicant | Thomas Medical Products, Inc., Malvern PA, US |
| Decision | Substantially Equivalent, Jun 1, 2004 |
| Received | Mar 18, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K040713
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 4, 2010 | Thomas Medical Products Inc Transseptal Sheath Introducer Kits (under trade names: HeartSpan, Channel FX, Torflex, Braided Guiding Introducer Kit). The product is shipped 5 per carton.
Intended to allow left heart catheterizati Terminated |
DYB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.