Company ยท US
Thomas Medical Products, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1990 to 2013. Name variants (Inc, Corp, punctuation) are merged.
23510(k) clearances (0 in 12 months)
17recalls (0 in 12 months)
11recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 29, 2013 | K122431 | HEARTSPAN STEERABLE INTRODUCER KIT Thomas Medical Products, Inc. | DYB |
| Aug 14, 2012 | K120158 | CORONARY SINUS GUIDE AND LATERAL VEIN INTRODUCER KITS Thomas Medical Products, Inc. | DYB |
| Sep 23, 2010 | K101015 | GUIDE CATHETERS AND ACCESSORIES Thomas Medical Products, Inc. | DQY |
| Feb 3, 2009 | K083269 | CROSSOVER Thomas Medical Products, Inc. | DYB |
| May 14, 2008 | K081341 | REINFORCED CATHETER INTRODUCER SYSTEM (RCIS) Thomas Medical Products, Inc. | DYB |
| Jan 4, 2008 | K072745 | Y-GLIDE Thomas Medical Products, Inc. | DTL |
| Feb 15, 2005 | K043438 | LARGE BORE SPLITTABLE INTRODUCER KIT Thomas Medical Products, Inc. | DYB |
| Jun 1, 2004 | K040713 | MODIFICATION TO BRAIDED GUIDING INTRODUCER SYSTEM Thomas Medical Products, Inc. | DYB |
| May 2, 2002 | K011727 | TRANSSEPTAL NEEDLE/TROCAR Thomas Medical Products, Inc. | DRC |
| Feb 11, 2002 | K020090 | MODIFICATION TO TRANSSEPTAL INTRODUCER SET Thomas Medical Products, Inc. | DYB |
| Oct 23, 2001 | K013202 | MODIFICATION TO BRAIDED GUIDING INTRODUCER Thomas Medical Products, Inc. | DYB |
| Jul 19, 2001 | K004025 | SPLITTABLE SHEATH INTRODUCER KIT Thomas Medical Products, Inc. | DYB |
| Jul 9, 2001 | K004026 | BRAIDED GUIDING INTRODUCER Thomas Medical Products, Inc. | DYB |
| Apr 10, 2001 | K003731 | SAFESHEATH MSP INTRODUCER SHEATH KIT WITH INTEGRAL HEMOSTASIS VALVE Thomas Medical Products, Inc. | DYB |
| Dec 24, 1996 | K961780 | HEMODIALYSIS INTRODUCER SET Thomas Medical Products, Inc. | DYB |
| Sep 12, 1996 | K961466 | PERCUTANEOUS INTRODUCER SET Thomas Medical Products, Inc. | DYB |
| Jan 21, 1994 | K934901 | TEAR-AWAY SHEATH INTRODUCER SET WITH INTEGRAL HEMOSTASIS VALVE Thomas Medical Products, Inc. | DYB |
| Oct 6, 1993 | K931587 | MULTI-PORT Y INTRODUCER SET Thomas Medical Products, Inc. | DYB |
| Aug 24, 1993 | K932619 | TRANSSEPTAL INTRODUCER SET Thomas Medical Products, Inc. | DQY |
| Mar 22, 1993 | K924456 | LONG LENGTH PERCUTANEOUS INTRODUCER SET Thomas Medical Products, Inc. | DYB |
| Jun 6, 1991 | K911130 | HEMOSTATIC Y CONNECTOR Thomas Medical Products, Inc. | LIT |
| Dec 3, 1990 | K904608 | PERCUTANEOUS INTRODUCER TRAY Thomas Medical Products, Inc. | DQY |
| Sep 26, 1990 | K902275 | PERCUTANEOUS INTRODUCER SET Thomas Medical Products, Inc. | DYB |
Latest recalls
| 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 | K003731 |
| 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 | K003731 K072745 +1 |
| 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 | K003731 |
| 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 | K934901 |
| 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 | K003731 K072745 +1 |
| 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 | K040713 |
| 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 | K003731 |
| Nov 24, 2009 | Thomas Medical Products Inc Reinforced Catheter Introducer System, 5 per carton. The product is sold under the Cordis Crossover and Cardiovascular Systems Inc (CSI) ViperSheath labels. Terminated |
DYB | K083269 |
| 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 | K003731 K934901 |
| 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 | K934901 |
| Oct 28, 2004 | Thomas Medical Products Inc SafeSheath KR under the Pressure Products label. Tearaway KR Kit. Catalog number HLS/KR-1011. The product is shipped in cartons containing 5 units 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-1009. The product is shipped in cartons containing 5 units. 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 | K934901 |
| Jul 20, 2004 | Thomas Medical Products Inc SafeSheath CSG (Coronary Sinus Guide) Worley-1-09 STD; CSG (Coronary Sinus Guide) Worley/BCor/-1-09; CSG (Coronary Sinus Guide)-2-09 Jumbo; CSG (Coronary Sinus Guide)/BCor/-2-09; CSG (Coronary Sinus Terminated |
DYB | None listed |
| Jul 20, 2004 | Thomas Medical Products Inc SafeSheath CSG (Coronary Sheath Guide) Multisite (MSP)-00-6.5 and CSG (Coronary Sheath Guide) Multisite-00.09 Terminated |
DYB | None listed |
| Jul 20, 2004 | Thomas Medical Products Inc SafeSheath CSG (Coronary Sinus Guide) KR-90.09 and CSG (Coronary Sinus Guide) KR/BCor-90.09. These sheaths are packaged in 5 individual boxed kits per case carton. Terminated |
DYB | None listed |
| Jul 20, 2004 | Thomas Medical Products Inc Safe Sheath CSG (Coronary Sinus Guide)-90.09; CSG (Coronary Sinus Guide)/BCor-90/09. These sheaths packaged in 5 individual boxed kits per case carton. Terminated |
DYB | None listed |