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FDA 510(k) Applications Submitted by Access Scientific, LLC
FDA 510(k) Number
Submission Date
Device Name
Applicant
K131148
04/23/2013
THE CVC WAND SAFETY INTRODUCER WITH VALVED PEELABLE SHEATH
ACCESS SCIENTIFIC, LLC
K131300
05/07/2013
THE POWERWAND SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER
ACCESS SCIENTIFIC, LLC
K181563
06/14/2018
The ARTERIAL WAND Safety Introducer with Arterial Catheter made of ChronoFlex C with BioGUARD Technology
Access Scientific, LLC
K182243
08/20/2018
The CVC WAND Safety Introducer with Valved Peelable Sheath
Access Scientific, LLC
K183066
11/05/2018
The POWERWAND Safety Introducer with an Extended Dwell Catheter made of ChronoFlex C« with BioGUARDÖ Technology-3 Fr, 4 Fr, and 5 Fr Model
Access Scientific, LLC
K162322
08/19/2016
the POWERWAND Safety Introducer with an Extended Dwell Catheter, 3Fr. Model
ACCESS SCIENTIFIC, LLC
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