510(k) K003731 ยท DYB Introducer, Catheter
SAFESHEATH MSP INTRODUCER SHEATH KIT WITH INTEGRAL HEMOSTASIS VALVE
| Applicant | Thomas Medical Products, Inc., Malvern PA, US |
| Decision | Substantially Equivalent, Apr 10, 2001 |
| Received | Dec 4, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K003731
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 11, 2012 | Thomas Medical Products Inc SafeSheath(R) CSG(R) Coronary Sinus guide Braided Core Hemostatic Introducer, SafeSheath(R) Worley Telescopic Braided Series, and Situs LDS2 Lead Delivery System - Catalog numbers: CSG/WORLEY/BCor-1-0 Terminated |
DYB | None listed |
| 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 MSP Introducer Sheath Kit with Integral Hemostasis Valve for use during vascular interventional procedures. SafeSheath Sealing Adapter, Part No. FCL-094-03, Catal 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 |
| Feb 2, 2010 | Thomas Medical Products Inc Thomas Medical Products Safesheath CSG (Coronary Sinus Guide) Hemostatic Tear away Introducer System with Infusion Side Port, for the introduction of various types of pacing or defibrillator leads and 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.