Access Scientific Inc
FDA Regulatory Profile
Access Scientific Inc appears in FDA public data with 14 recalls, 14 510(k) clearances, 3 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2550-2020, Class III) was initiated on June 15, 2020. Its most recent 510(k) clearance was granted on July 25, 2019.
Summary
- Total Recalls
- 14
- 510(k) Clearances
- 14
- Inspections
- 3
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2550-2020 | Class III | POWERWAND XL 4Fr 8cm Maximum Barrier Kit (Introducer with an Extended Dwell Catheter made of ChronoF | June 15, 2020 |
| Z-1980-2020 | Class II | BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 3Fr 6cm Quick Kit. REF/UDI / 94123/1 | April 23, 2020 |
| Z-1975-2020 | Class II | BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 10cm Quick Kit. REF/UDI / 94105/ | April 23, 2020 |
| Z-1976-2020 | Class II | BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 8cm Max Barrier Kit. REF/UDI / 9 | April 23, 2020 |
| Z-1972-2020 | Class II | BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND" ED Quick Kit 3FR 6cm. REF/UDI 72627/ 0 | April 23, 2020 |
| Z-1983-2020 | Class II | BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 5Fr 8cm Max Barrier Kit. REF/UDI / 9 | April 23, 2020 |
| Z-1979-2020 | Class II | BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 10cm Extended Dwell Catheter. RE | April 23, 2020 |
| Z-1977-2020 | Class II | BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 10cm Max Barrier Kit. REF/UDI / | April 23, 2020 |
| Z-1981-2020 | Class II | BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 3Fr 6cm Pediatric Kit. REF/UDI / 941 | April 23, 2020 |
| Z-1973-2020 | Class II | BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND"XL Alternate Site Kit, 4Fr . REF/UDI 80 | April 23, 2020 |
| Z-1982-2020 | Class II | BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 5Fr 10cm Quick Kit. REF/UDI / 94115/ | April 23, 2020 |
| Z-1978-2020 | Class II | BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 5Fr 8cm Quick Kit. REF/UDI / 94114/1 | April 23, 2020 |
| Z-1974-2020 | Class II | BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 8cm Quick Kit. REF/UDI / 94104/1 | April 23, 2020 |
| Z-2254-2013 | Class II | POWERWAND Safety Introducer with Extended Dwell Catheter; Catalog no. 92006. Used to gain access | August 16, 2013 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K183066 | The POWERWAND Safety Introducer with an Extended Dwell Catheter made of ChronoFlex C® with BioGUARD | July 25, 2019 |
| K181563 | The ARTERIAL WAND Safety Introducer with Arterial Catheter made of ChronoFlex C with BioGUARD Techno | September 26, 2018 |
| K182243 | The CVC WAND Safety Introducer with Valved Peelable Sheath | September 18, 2018 |
| K162322 | the POWERWAND Safety Introducer with an Extended Dwell Catheter, 3Fr. Model | November 17, 2016 |
| K131148 | THE CVC WAND SAFETY INTRODUCER WITH VALVED PEELABLE SHEATH | September 4, 2013 |
| K131300 | THE POWERWAND SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER | June 7, 2013 |
| K121748 | THE POWERWAND SAFETY INTRODUCER WITH AND EXTENDED DWELL | July 27, 2012 |
| K111417 | THE POWERWAND (R) SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER | July 15, 2011 |
| K111138 | THE PICC WAND (R) PEELABLE SAFETY INTRODUCER | June 22, 2011 |
| K101422 | THE POWER WAND SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER | March 22, 2011 |
| K101150 | PICC WAND PEELABLE SAFETY INTRODUCER | August 13, 2010 |
| K093022 | THE PICC WAND PEELABLE SAFETY INTRODUCER | January 20, 2010 |
| K090372 | THE WAND MICROACCESS SAFETY INTRODUCER | March 30, 2009 |
| K081697 | THE WAND MICROACCESS SAFETY INTRODUCER, MODELS 90001, 90002, 90005, 90006 | December 4, 2008 |