Access Scientific, LLC - FDA 510(k) Cleared Devices
Recent clearances: The POWERWAND Safety Introducer with an Extended Dwell Catheter made of ChronoFlex C® with BioGUARD™ Technology-3 Fr, 4 Fr, and 5 Fr Model, The ARTERIAL WAND Safety Introducer with Arterial Catheter made of ChronoFlex C with BioGUARD Technology, The CVC WAND Safety Introducer with Valved Peelable Sheath
6
Total
6
Cleared
0
Denied
FDA 510(k) Regulatory Record - Access Scientific, LLC Cardiovascular ✕
6 devices
Cleared
Jul 25, 2019
The POWERWAND Safety Introducer with an Extended Dwell Catheter made of...
Cardiovascular
262d
Cleared
Sep 26, 2018
The ARTERIAL WAND Safety Introducer with Arterial Catheter made of ChronoFlex...
Cardiovascular
104d
Cleared
Sep 18, 2018
The CVC WAND Safety Introducer with Valved Peelable Sheath
Cardiovascular
29d
Cleared
Nov 17, 2016
the POWERWAND Safety Introducer with an Extended Dwell Catheter, 3Fr. Model
Cardiovascular
90d
Cleared
Sep 04, 2013
THE CVC WAND SAFETY INTRODUCER WITH VALVED PEELABLE SHEATH
Cardiovascular
134d
Cleared
Jun 07, 2013
THE POWERWAND SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER
Cardiovascular
31d