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Thomas Medical Products, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
23
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K122431HEARTSPAN STEERABLE INTRODUCER KITJanuary 29, 2013
K120158CORONARY SINUS GUIDE AND LATERAL VEIN INTRODUCER KITSAugust 14, 2012
K101015GUIDE CATHETERS AND ACCESSORIESSeptember 23, 2010
K083269CROSSOVERFebruary 3, 2009
K081341REINFORCED CATHETER INTRODUCER SYSTEM (RCIS)May 14, 2008
K072745Y-GLIDEJanuary 4, 2008
K043438LARGE BORE SPLITTABLE INTRODUCER KITFebruary 15, 2005
K040713MODIFICATION TO BRAIDED GUIDING INTRODUCER SYSTEMJune 1, 2004
K011727TRANSSEPTAL NEEDLE/TROCARMay 2, 2002
K020090MODIFICATION TO TRANSSEPTAL INTRODUCER SETFebruary 11, 2002
K013202MODIFICATION TO BRAIDED GUIDING INTRODUCEROctober 23, 2001
K004025SPLITTABLE SHEATH INTRODUCER KITJuly 19, 2001
K004026BRAIDED GUIDING INTRODUCERJuly 9, 2001
K003731SAFESHEATH MSP INTRODUCER SHEATH KIT WITH INTEGRAL HEMOSTASIS VALVEApril 10, 2001
K961780HEMODIALYSIS INTRODUCER SETDecember 24, 1996
K961466PERCUTANEOUS INTRODUCER SETSeptember 12, 1996
K934901TEAR-AWAY SHEATH INTRODUCER SET WITH INTEGRAL HEMOSTASIS VALVEJanuary 21, 1994
K931587MULTI-PORT Y INTRODUCER SETOctober 6, 1993
K932619TRANSSEPTAL INTRODUCER SETAugust 24, 1993
K924456LONG LENGTH PERCUTANEOUS INTRODUCER SETMarch 22, 1993