Company ยท US
Fenwal Inc
FDA 510(k) clearances and medical device recalls filed under this name, 2008 to 2014. Name variants (Inc, Corp, punctuation) are merged.
3510(k) clearances (0 in 12 months)
10recalls (0 in 12 months)
8recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 10, 2014 | K141019 | AMICUS SEPARATOR SYSTEM/ AMICUS SEPERATOR SYSTEM;REFURBISHED Fenwal, Inc. | LKN |
| Mar 22, 2012 | K111702 | AMICUS SEPARATOR SYSTEM- USE IN THERAPEUTIC PLASMA EXCHANGE AND FILTER SET FOR AMICUS TPE Fenwal, Inc. | LKN |
| Mar 3, 2008 | K073339 | BLOOD COMPONENT RECIPIENT SET WITH STANDARD SIZE FILTER AND INFUSION SET WITH SIDE ARM LUER CONNECTOR Fenwal, Inc. | BRZ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 15, 2023 | Fenwal Inc Amicus Exchange Kit Therapeutics. Component of Amicus Separator multiprocedural apheresis platform Open, Classified |
LKN | K180615 |
| Mar 15, 2023 | Fenwal Inc Amicus MNC Apheresis Kit Double Needle. Component of Amicus Separator multiprocedural apheresis platform Open, Classified |
LKN | K180615 |
| Feb 25, 2021 | Fenwal Inc Amicus Exchange Kit Therapeutics - Product Usage: intended for use in the collection of blood components and mononuclear cells. Terminated |
LKN | K180615 |
| Feb 25, 2021 | Fenwal Inc Amicus Exchange Kit - Product Usage: intended for use in the collection of blood components and mononuclear cells. Terminated |
LKN | K180615 |
| Feb 25, 2021 | Fenwal Inc Amicus MNC Apheresis Kit - Double Needle - Product Usage: intended for use in the collection of blood components and mononuclear cells. Terminated |
GKT | None listed |
| Aug 12, 2019 | Fenwal Inc Vigilant Agilia, Vigilant Drug'Lib, REF Z073476, versions 1.0 and 1.1
Product Usage:
Vigilant Drug Lib is Dose Error Reduction Software that, when used in combination with Volumat MC Agilia infusion Terminated |
PHC | None listed |
| Aug 12, 2019 | Fenwal Inc VOLUMAT MC AGILIA US, Infusion Pump, REF Z021135, software versions 1.7 and 1.9a
Product Usage:
The Volumat MC Agilia is a piece of transportable medical equipment intended to be used in healthcare f Terminated |
FRN | K121613 |
| Mar 5, 2019 | Fenwal Inc Fresenius Kabi CATSmart device (Continuous autotransfusion System). Labeled as the following kits:
1. AT-1 sets and kits (9005104 AT-1 Autotransfusion set, 9108504 ATF 120 Fast Start Kit, and 91 Terminated |
CAC | K160735 |
| Feb 11, 2019 | Fenwal Inc Vacuum Unit for CATSmart Vacuum Pump.
Fresenius CATSmart (Continuous Autotransfusion System) is indicated for the processing of blood collected intraoperatively and postoperatively to obtain washed p Terminated |
CAC | K180831 |
| Jun 8, 2013 | Fenwal Inc AMICUS Exchange Kit;
Product Usage:
This kit is designed for use with the AMICUS separator for the Therapeutic Plasma Exchange (TPE) procedure. Sterilized by irradiation. Sterile fluid path. Non-pyr Terminated |
LKN | K111702 |