Company · US
Access Scientific LLC
FDA 510(k) clearances and medical device recalls filed under this name, 2008 to 2019. Name variants (Inc, Corp, punctuation) are merged.
14510(k) clearances (0 in 12 months)
14recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 25, 2019 | K183066 | The POWERWAND Safety Introducer with an Extended Dwell Catheter made of ChronoFlex C® with BioGUARD Technology-3 Fr, 4 Access Scientific, LLC | DYB |
| Sep 26, 2018 | K181563 | The ARTERIAL WAND Safety Introducer with Arterial Catheter made of ChronoFlex C with BioGUARD Technology Access Scientific, LLC | DQY |
| Sep 18, 2018 | K182243 | The CVC WAND Safety Introducer with Valved Peelable Sheath Access Scientific, LLC | DYB |
| Nov 17, 2016 | K162322 | the POWERWAND Safety Introducer with an Extended Dwell Catheter, 3Fr. Model Access Scientific, LLC | DYB |
| Sep 4, 2013 | K131148 | THE CVC WAND SAFETY INTRODUCER WITH VALVED PEELABLE SHEATH Access Scientific, LLC | DYB |
| Jun 7, 2013 | K131300 | THE POWERWAND SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER Access Scientific, LLC | DYB |
| Jul 27, 2012 | K121748 | THE POWERWAND SAFETY INTRODUCER WITH AND EXTENDED DWELL Access Scientific, Inc. | DYB |
| Jul 15, 2011 | K111417 | THE POWERWAND (R) SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER Access Scientific, Inc. | DYB |
| Jun 22, 2011 | K111138 | THE PICC WAND (R) PEELABLE SAFETY INTRODUCER Access Scientific, Inc. | DYB |
| Mar 22, 2011 | K101422 | THE POWER WAND SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER Access Scientific, Inc. | DYB |
| Aug 13, 2010 | K101150 | PICC WAND PEELABLE SAFETY INTRODUCER Access Scientific, Inc. | DYB |
| Jan 20, 2010 | K093022 | THE PICC WAND PEELABLE SAFETY INTRODUCER Access Scientific, Inc. | DYB |
| Mar 30, 2009 | K090372 | THE WAND MICROACCESS SAFETY INTRODUCER Access Scientific, Inc. | DYB |
| Dec 4, 2008 | K081697 | THE WAND MICROACCESS SAFETY INTRODUCER, MODELS 90001, 90002, 90005, 90006 Access Scientific, Inc. | DYB |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 15, 2020 | Access Scientific LLC POWERWAND XL 4Fr 8cm Maximum Barrier Kit (Introducer with an Extended Dwell Catheter made of ChronoFlex C with BioGUARD Technology), Catalog No. 94108, Device UDI 00859821006773/Pacakge UDI 1085982100 Terminated |
OWL | None listed |
| May 14, 2020 | Access Scientific LLC BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 5Fr 8cm Max Barrier Kit. REF/UDI / 94116/10859821006237 - Product Usage: is used to gain access to the vascular system to sample blood a Terminated |
FMF | None listed |
| May 14, 2020 | Access Scientific LLC BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 5Fr 10cm Quick Kit. REF/UDI / 94115/10859821006251 - Product Usage: is used to gain access to the vascular system to sample blood and ad Terminated |
FMF | None listed |
| May 14, 2020 | Access Scientific LLC BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 3Fr 6cm Pediatric Kit. REF/UDI / 94124/10859821006480 - Product Usage: is used to gain access to the vascular system to sample blood and Terminated |
FMF | None listed |
| May 14, 2020 | Access Scientific LLC BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 3Fr 6cm Quick Kit. REF/UDI / 94123/10859821006473 - Product Usage: is used to gain access to the vascular system to sample blood and adm Terminated |
FMF | None listed |
| May 14, 2020 | Access Scientific LLC BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 10cm Extended Dwell Catheter. REF/UDI / 94108/00859821006773 - Product Usage: is used to gain access to the vascular system to sampl Terminated |
FMF | None listed |
| May 14, 2020 | Access Scientific LLC BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 5Fr 8cm Quick Kit. REF/UDI / 94114/10859821006220 - Product Usage: is used to gain access to the vascular system to sample blood and adm Terminated |
FMF | None listed |
| May 14, 2020 | Access Scientific LLC BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 10cm Max Barrier Kit. REF/UDI / 94107/10859821006206 - Product Usage: is used to gain access to the vascular system to sample blood Terminated |
FMF | None listed |
| May 14, 2020 | Access Scientific LLC BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 8cm Max Barrier Kit. REF/UDI / 94106/10859821006176 - Product Usage: is used to gain access to the vascular system to sample blood a Terminated |
FMF | None listed |
| May 14, 2020 | Access Scientific LLC BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 10cm Quick Kit. REF/UDI / 94105/10859821006190 - Product Usage: is used to gain access to the vascular system to sample blood and ad Terminated |
FMF | None listed |
| May 14, 2020 | Access Scientific LLC BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 8cm Quick Kit. REF/UDI / 94104/10859821006169 - Product Usage: is used to gain access to the vascular system to sample blood and adm Terminated |
FMF | None listed |
| May 14, 2020 | Access Scientific LLC BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND"XL Alternate Site Kit, 4Fr . REF/UDI 80701/10859821006213 - Product Usage: is used to gain access to the vascular system to sample blood an Terminated |
FMF | None listed |
| May 14, 2020 | Access Scientific LLC BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND" ED Quick Kit 3FR 6cm. REF/UDI 72627/ 00859821006674 - Product Usage: is used to gain access to the vascular system to sample blood and adm Terminated |
FMF | None listed |
| Sep 18, 2013 | Access Scientific Inc POWERWAND Safety Introducer with Extended Dwell Catheter;
Catalog no. 92006.
Used to gain access to the vascular system to sample blood and administer fluids intravenously. Terminated |
DYB | K111417 K121748 +1 |