Medical Device Manufacturer · US , Mission Viejo , CA

Ep Dynamics, Inc. - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 2009

Recent clearances: LINEBACKER(TM) TRANSSEPTAL INTRODUCER, 53CM / 62CM / 72CM, AIRBLOC TRANSSEPTAL INTRODUCER, 53 CM, MODEL FA001, AIRBLOCK TRANSSEPTAL INTRODUCER, 72 CM ,MODEL FA002

View 2 510(k) Devices ↓

2

Total

2

Cleared

0

Denied

FDA 510(k) Regulatory Record - Ep Dynamics, Inc. Cardiovascular ✕

2 devices

1-2 of 2

Cleared Aug 23, 2012

LINEBACKER(TM) TRANSSEPTAL INTRODUCER, 53CM / 62CM / 72CM

Cardiovascular · 442d

Cleared Jul 30, 2009

AIRBLOC TRANSSEPTAL INTRODUCER, 53 CM, MODEL FA001, AIRBLOCK TRANSSEPTAL...

Cardiovascular · 121d