Medical Device Manufacturer · US , Minneapolis , MN

Enpath Medical Incorporated - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 2004

Recent clearances: ENPATH DEFLECTABLE CATHETER, ENPATH SAFETY INTRODUCER

View 2 510(k) Devices ↓

2

Total

2

Cleared

0

Denied

FDA 510(k) Regulatory Record - Enpath Medical Incorporated Cardiovascular ✕

2 devices

1-2 of 2

Cleared May 19, 2005

ENPATH DEFLECTABLE CATHETER

Cardiovascular · 153d

Cleared Nov 30, 2004

ENPATH SAFETY INTRODUCER

Cardiovascular · 160d

Data Source

Sourced from the FDA 510(k) public files . 176,325 total devices indexed.

Last updated: Sep 25, 2026