ClearanceBrief
510(k) K021395 ยท FPA Set, Administration, Intravascular

MODIFICATION TO 30 EXTENSION SET

ApplicantChurchill Medical Systems, Inc., Dover NH, US
DecisionSubstantially Equivalent, May 13, 2002
ReceivedMay 2, 2002
TypeSpecial
FDA recordOpen on fda.gov

Recalls that name K021395

DateFirm and productCodeLinked 510(k)
Feb 20, 2017Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.
AMS-636, 60" Microbore extension set. Product Usage: Accessory devices used to administer medical fluids.
Terminated
FPANone listed
Nov 18, 2016Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.
AMS-651, 120" Microbore extension set with slide clamp; Product Code: AMS-651 Product Usage: Accessory devices used to administer medical fluids.
Terminated
FPANone listed
Apr 21, 2015Churchill Medical Systems, Inc.
6" Trifurcated Extension Set, Product Code: AMS-375-1 Accessory device used to administer medical fluids
Terminated
FPANone listed
Apr 21, 2015Churchill Medical Systems, Inc.
Bifircated Extension Set, Product Code: BN-828 Accessory device used to administer medical fluids
Terminated
FPANone listed
Apr 21, 2015Churchill Medical Systems, Inc.
4" Microbore Double Lumen Set with Bionector, Product Code: BN-208 Accessory device used to administer medical fluids
Terminated
FPANone listed
Apr 21, 2015Churchill Medical Systems, Inc.
4" Microbore Trifurcated Ext set, Product Code: BN-308 Accessory device used to administer medical fluids
Terminated
FPANone listed
Apr 21, 2015Churchill Medical Systems, Inc.
4" Microbore T-Port Set, Product Code: BN-448 Accessory device used to administer medical fluids
Terminated
FPANone listed
Apr 21, 2015Churchill Medical Systems, Inc.
8" Standard Bore Ext Set, Product Code: BN-481 Accessory device used to administer medical fluids
Terminated
FPANone listed
Apr 21, 2015Churchill Medical Systems, Inc.
7" High Pressure Set with Bionector, Product Code: CMS-808 and CMS-808-1 Accessory device used to administer medical fluids
Terminated
FPANone listed
Apr 21, 2015Churchill Medical Systems, Inc.
7" Standard Bore High Pressure Ext Set, Product Code: CMS-809 Accessory device used to administer medical fluids
Terminated
FPANone listed
Apr 21, 2015Churchill Medical Systems, Inc.
7" Standard Bore High Pressure Ext Set, Product Code: CMS-809 Accessory device used to administer medical fluids
Terminated
FPANone listed
Apr 21, 2015Churchill Medical Systems, Inc.
Bifurcated set with check vales and Bionectors, Product Code: BN-2082CV Accessory device used to administer medical fluids
Terminated
FPANone listed
Apr 21, 2015Churchill Medical Systems, Inc.
4" Trifurcated set with Bionectors and check valves, Product Code: BN-3082CV and BN-3083CV Accessory device used to administer medical fluids
Terminated
FPANone listed
Apr 21, 2015Churchill Medical Systems, Inc.
6" Trifurcated set with Bionectors, Product Code: BN-944 Accessory device used to administer medical fluids
Terminated
FPANone listed
Jan 23, 2014Churchill Medical Systems, Inc.
AMS-530 7 Microbore Trifurcated Extension sets Product Usage: Intravascular administration set.
Terminated
FPANone listed
Feb 16, 2011Churchill Medical Systems, Inc.
Churchill Medical 78" Stopcock Extension Set with male/female red cap; item # AMS-464-1 Intended use: Intravascular Administration Set
Terminated
FPANone listed
Feb 16, 2011Churchill Medical Systems, Inc.
Churchill Medical Systems 6" Microbore Trifurcated non-DEHP Extension Set with male/Female Luer Locks Slide Clamps & 0.2 Micron Filter Item Number: AMS-944 Intended use: Intravascular Administration
Terminated
FPANone listed
Feb 16, 2011Churchill Medical Systems, Inc.
Churchill Medical Systems 14"Extension Set with SmartSite Injection Item # 43000E Intended use: Intravascular Administration Set
Terminated
FPANone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.