Enpath Medical, Inc. - FDA 510(k) Cleared Devices
Recent clearances: PTFE INTERLOCK PEELABLE INTRODUCERS, VIAPEEL PEELABLE INTRODUCER, STIFFER COAXIAL MICRO-INTRODUCER KIT
5
Total
5
Cleared
0
Denied
FDA 510(k) Regulatory Record - Enpath Medical, Inc. Cardiovascular ✕
5 devices
Cleared
Sep 15, 2008
PTFE INTERLOCK PEELABLE INTRODUCERS
Cardiovascular
119d
Cleared
Nov 09, 2007
VIAPEEL PEELABLE INTRODUCER
Cardiovascular
88d
Cleared
Jul 05, 2007
STIFFER COAXIAL MICRO-INTRODUCER KIT
Cardiovascular
27d
Cleared
Dec 21, 2006
ENPATH MEDICAL VIASEAL VALVED PEELABLE INTRODUCER, MODEL 10866-XXX
Cardiovascular
63d
Cleared
May 18, 2006
ENPATH MEDICAL STEERABLE SHEATH
Cardiovascular
27d