Medical Device Manufacturer · US , Phoenix , AZ

Ascent Healthcare Solutions - FDA 510(k) Cleared Devices

21 submissions · 21 cleared · Since 2006

21

Total

21

Cleared

0

Denied

FDA 510(k) Regulatory Record - Ascent Healthcare Solutions Cardiovascular ✕

9 devices

1-9 of 9

Cleared Jul 23, 2010

REPROCESSED COMPRESSION SLEEVES

Cardiovascular · 113d

Cleared May 28, 2010

REPROCESSED CS BI-DIECTIONAL DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER

Cardiovascular · 120d

Cleared Oct 21, 2009

REPROCESSED 3D DIAGNOSTIC ULTRASOUND CATHETERS, MODEL SNDSTR10

Cardiovascular · 75d

Cleared Apr 01, 2009

REPROCESSED ELECTROPHYSIOLOGY CATHETERS

Cardiovascular · 51d

Cleared Sep 16, 2008

REPROCESSED ELECTROPHYSIOLOGY CATHETERS

Cardiovascular · 62d

Cleared Jul 09, 2008

REPROCESSED ELECTROPHYSIOLOGY CATHETERS

Cardiovascular · 58d

Cleared Aug 17, 2007

REPROCESSED GUIDANT CARDIAC STABILIZATION AND POSITIONING DEVICES

Cardiovascular · 226d

Cleared Aug 17, 2007

REPROCESSED MEDTRONIC CARDIAC STABILIZATION AND POSITIONING DEVICES

Cardiovascular · 226d

Cleared Mar 29, 2007

REPROCESSED DIAGNOSTIC ULTRASOUND CATHETER

Cardiovascular · 174d