510(k) K934901 ยท DYB Introducer, Catheter
TEAR-AWAY SHEATH INTRODUCER SET WITH INTEGRAL HEMOSTASIS VALVE
| Applicant | Thomas Medical Products, Inc., Malvern PA, US |
| Decision | Substantially Equivalent, Jan 21, 1994 |
| Received | Oct 14, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K934901
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 14, 2011 | Thomas Medical Products Inc Thomas Medical Products, Y-Glide (Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass) for use during vascular interventional procedures. Part No. FTB-021-00, Catalog No. FTB-021-00. Terminated |
DTL | None listed |
| Feb 14, 2011 | Thomas Medical Products Inc Thomas Medical Products, SafeSheath Long, (Tear-Away Sheath Introducer Set with Integral Hemostasis Valve) for use during vascular interventional procedures. Part No. FCL-051-00, Catalog No. HLS2507M Terminated |
DYB | None listed |
| Feb 14, 2011 | Thomas Medical Products Inc Thomas Medical Products, Acuity Bleed back Control Valve, Acuity Rotating Hemostasis Valve, Acuity Universal Cutter, and Contamination Sleeve for use during vascular interventional procedures. Contam Terminated |
DQY | None listed |
| Nov 7, 2008 | C. R.Bard, Inc./BardElectrophysiology Division 7F Bard SSV 13 cm Split Sheath with Valve and sideport
Catalog Number: 808700
Distributed By: Bard Electrophysiology. The product is Intended for introduction of various type of pacing leads and cath Terminated |
DYB | None listed |
| Nov 3, 2008 | Thomas Medical Products Inc 18 gage XTW needles, sold as a component in SafeSheath Hemostatic Tear-away Introducer System with Infusion Side Port kits or sold Bulk Non Sterile (BNS). Terminated |
DYB | None listed |
| Dec 17, 2005 | Thomas Medical Products Inc Bard electrophysiology SSV H. Lee 9.5F split sheath with valve and sideport. The product is packaged in individual pouches and shipped 5 pouches per case. Terminated |
DYB | None listed |
| Oct 28, 2004 | Thomas Medical Products Inc SafeSheath KR under the Pressure Products label. Tearaway KR Kit. Catalog number HLS/KR-1007. The product is shipped in cartons containing 5 units Terminated |
DYB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.