Access Scientific LLC
Medical device manufacturer in San Diego, CA.
14510(k) clearances
0PMA approvals
14recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K183066 | The POWERWAND Safety Introducer with an Extended Dwell Catheter made of ChronoFlex C®…DYB · Traditional | 07/25/2019SE |
| K181563 | The ARTERIAL WAND Safety Introducer with Arterial Catheter made of ChronoFlex C with…DQY · Traditional | 09/26/2018SE |
| K182243 | The CVC WAND Safety Introducer with Valved Peelable SheathDYB · Special | 09/18/2018SE |
| K162322 | the POWERWAND Safety Introducer with an Extended Dwell Catheter, 3Fr. ModelDYB · Traditional | 11/17/2016SE |
| K131148 | The CVC Wand Safety Introducer with Valved Peelable SheathDYB · Traditional | 09/04/2013SE |
| K131300 | The Powerwand Safety Introducer with an Extended Dwell CatheterDYB · Special | 06/07/2013SE |
| K121748 | The Powerwand Safety Introducer with and Extended DwellDYB · Special | 07/27/2012SE |
| K111417 | The Powerwand (R) Safety Introducer with an Extended Dwell CatheterDYB · Special | 07/15/2011SE |
| K111138 | The Picc Wand (R) Peelable Safety IntroducerDYB · Special | 06/22/2011SE |
| K101422 | The Power Wand Safety Introducer with an Extended Dwell CatheterDYB · Traditional | 03/22/2011SE |
| K101150 | Picc Wand Peelable Safety IntroducerDYB · Special | 08/13/2010SE |
| K093022 | The Picc Wand Peelable Safety IntroducerDYB · Traditional | 01/20/2010SE |
| K090372 | The Wand Microaccess Safety IntroducerDYB · Traditional | 03/30/2009SE |
| K081697 | The Wand Microaccess Safety Introducer, Models 90001, 90002, 90005, 90006DYB · Traditional | 12/04/2008SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-2550-2020 Class III | POWERWAND XL 4Fr 8cm Maximum Barrier Kit (Introducer with an Extended Dwell Catheter…Convenience kit mislabeled with the incorrect catheter effective length on the device label and the… | 06/15/2020Terminated |
| Z-1983-2020 Class II | BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 5Fr 8cm Max Barrier Kit.…Saline Flush Syringe compromised sterility due to holes in the packaging. | 04/23/2020Terminated |
| Z-1982-2020 Class II | BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 5Fr 10cm Quick Kit.…Saline Flush Syringe compromised sterility due to holes in the packaging. | 04/23/2020Terminated |
| Z-1981-2020 Class II | BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 3Fr 6cm Pediatric Kit.…Saline Flush Syringe compromised sterility due to holes in the packaging. | 04/23/2020Terminated |
| Z-1980-2020 Class II | BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 3Fr 6cm Quick Kit.…Saline Flush Syringe compromised sterility due to holes in the packaging. | 04/23/2020Terminated |
| Z-1979-2020 Class II | BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 10cm Extended Dwell…Saline Flush Syringe compromised sterility due to holes in the packaging. | 04/23/2020Terminated |
| Z-1978-2020 Class II | BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 5Fr 8cm Quick Kit.…Saline Flush Syringe compromised sterility due to holes in the packaging. | 04/23/2020Terminated |
| Z-1977-2020 Class II | BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 10cm Max Barrier…Saline Flush Syringe compromised sterility due to holes in the packaging. | 04/23/2020Terminated |
| Z-1976-2020 Class II | BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 8cm Max Barrier Kit.…Saline Flush Syringe compromised sterility due to holes in the packaging. | 04/23/2020Terminated |
| Z-1975-2020 Class II | BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 10cm Quick Kit.…Saline Flush Syringe compromised sterility due to holes in the packaging. | 04/23/2020Terminated |
| Z-1974-2020 Class II | BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 8cm Quick Kit.…Saline Flush Syringe compromised sterility due to holes in the packaging. | 04/23/2020Terminated |
| Z-1973-2020 Class II | BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND"XL Alternate Site Kit, 4Fr…Saline Flush Syringe compromised sterility due to holes in the packaging. | 04/23/2020Terminated |
| Z-1972-2020 Class II | BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND" ED Quick Kit 3FR 6cm.…Saline Flush Syringe compromised sterility due to holes in the packaging. | 04/23/2020Terminated |
| Z-2254-2013 Class II | POWERWAND Safety Introducer with Extended Dwell Catheter; Catalog no. 92006. Used to…Access Scientific is recalling the POWERWAND Saftey Introducer with Extended Dwell Catheter because it is… | 08/16/2013Terminated |