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Access Scientific Inc

FDA Regulatory Profile

Summary

Total Recalls
14
510(k) Clearances
14
Inspections
3
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2550-2020Class IIIPOWERWAND XL 4Fr 8cm Maximum Barrier Kit (Introducer with an Extended Dwell Catheter made of ChronoFJune 15, 2020
Z-1980-2020Class IIBD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 3Fr 6cm Quick Kit. REF/UDI / 94123/1April 23, 2020
Z-1978-2020Class IIBD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 5Fr 8cm Quick Kit. REF/UDI / 94114/1April 23, 2020
Z-1976-2020Class IIBD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 8cm Max Barrier Kit. REF/UDI / 9April 23, 2020
Z-1972-2020Class IIBD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND" ED Quick Kit 3FR 6cm. REF/UDI 72627/ 0April 23, 2020
Z-1977-2020Class IIBD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 10cm Max Barrier Kit. REF/UDI / April 23, 2020
Z-1982-2020Class IIBD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 5Fr 10cm Quick Kit. REF/UDI / 94115/April 23, 2020
Z-1981-2020Class IIBD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 3Fr 6cm Pediatric Kit. REF/UDI / 941April 23, 2020
Z-1973-2020Class IIBD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND"XL Alternate Site Kit, 4Fr . REF/UDI 80April 23, 2020
Z-1983-2020Class IIBD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 5Fr 8cm Max Barrier Kit. REF/UDI / 9April 23, 2020
Z-1979-2020Class IIBD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 10cm Extended Dwell Catheter. REApril 23, 2020
Z-1975-2020Class IIBD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 10cm Quick Kit. REF/UDI / 94105/April 23, 2020
Z-1974-2020Class IIBD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 8cm Quick Kit. REF/UDI / 94104/1April 23, 2020
Z-2254-2013Class IIPOWERWAND Safety Introducer with Extended Dwell Catheter; Catalog no. 92006. Used to gain accessAugust 16, 2013

Recent 510(k) Clearances

K-NumberDeviceDate
K183066The POWERWAND Safety Introducer with an Extended Dwell Catheter made of ChronoFlex C® with BioGUARD™July 25, 2019
K181563The ARTERIAL WAND Safety Introducer with Arterial Catheter made of ChronoFlex C with BioGUARD TechnoSeptember 26, 2018
K182243The CVC WAND Safety Introducer with Valved Peelable SheathSeptember 18, 2018
K162322the POWERWAND Safety Introducer with an Extended Dwell Catheter, 3Fr. ModelNovember 17, 2016
K131148THE CVC WAND SAFETY INTRODUCER WITH VALVED PEELABLE SHEATHSeptember 4, 2013
K131300THE POWERWAND SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETERJune 7, 2013
K121748THE POWERWAND SAFETY INTRODUCER WITH AND EXTENDED DWELLJuly 27, 2012
K111417THE POWERWAND (R) SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETERJuly 15, 2011
K111138THE PICC WAND (R) PEELABLE SAFETY INTRODUCERJune 22, 2011
K101422THE POWER WAND SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETERMarch 22, 2011
K101150PICC WAND PEELABLE SAFETY INTRODUCERAugust 13, 2010
K093022THE PICC WAND PEELABLE SAFETY INTRODUCERJanuary 20, 2010
K090372THE WAND MICROACCESS SAFETY INTRODUCERMarch 30, 2009
K081697THE WAND MICROACCESS SAFETY INTRODUCER, MODELS 90001, 90002, 90005, 90006December 4, 2008