510(k) K021395 ยท FPA Set, Administration, Intravascular
MODIFICATION TO 30 EXTENSION SET
| Applicant | Churchill Medical Systems, Inc., Dover NH, US |
| Decision | Substantially Equivalent, May 13, 2002 |
| Received | May 2, 2002 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K021395
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 20, 2017 | Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc. AMS-636, 60" Microbore extension set.
Product Usage:
Accessory devices used to administer medical fluids. Terminated |
FPA | None listed |
| Nov 18, 2016 | Vygon 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 |
FPA | None listed |
| Apr 21, 2015 | Churchill Medical Systems, Inc. 6" Trifurcated Extension Set, Product Code: AMS-375-1
Accessory device used to administer medical fluids Terminated |
FPA | None listed |
| Apr 21, 2015 | Churchill Medical Systems, Inc. Bifircated Extension Set, Product Code: BN-828
Accessory device used to administer medical fluids Terminated |
FPA | None listed |
| Apr 21, 2015 | Churchill Medical Systems, Inc. 4" Microbore Double Lumen Set with Bionector, Product Code: BN-208
Accessory device used to administer medical fluids Terminated |
FPA | None listed |
| Apr 21, 2015 | Churchill Medical Systems, Inc. 4" Microbore Trifurcated Ext set, Product Code: BN-308
Accessory device used to administer medical fluids Terminated |
FPA | None listed |
| Apr 21, 2015 | Churchill Medical Systems, Inc. 4" Microbore T-Port Set, Product Code: BN-448
Accessory device used to administer medical fluids Terminated |
FPA | None listed |
| Apr 21, 2015 | Churchill Medical Systems, Inc. 8" Standard Bore Ext Set, Product Code: BN-481
Accessory device used to administer medical fluids Terminated |
FPA | None listed |
| Apr 21, 2015 | Churchill 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 |
FPA | None listed |
| Apr 21, 2015 | Churchill Medical Systems, Inc. 7" Standard Bore High Pressure Ext Set, Product Code: CMS-809
Accessory device used to administer medical fluids Terminated |
FPA | None listed |
| Apr 21, 2015 | Churchill Medical Systems, Inc. 7" Standard Bore High Pressure Ext Set, Product Code: CMS-809
Accessory device used to administer medical fluids Terminated |
FPA | None listed |
| Apr 21, 2015 | Churchill Medical Systems, Inc. Bifurcated set with check vales and Bionectors, Product Code: BN-2082CV
Accessory device used to administer medical fluids Terminated |
FPA | None listed |
| Apr 21, 2015 | Churchill 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 |
FPA | None listed |
| Apr 21, 2015 | Churchill Medical Systems, Inc. 6" Trifurcated set with Bionectors, Product Code: BN-944
Accessory device used to administer medical fluids Terminated |
FPA | None listed |
| Jan 23, 2014 | Churchill Medical Systems, Inc. AMS-530 7 Microbore Trifurcated Extension sets
Product Usage: Intravascular administration set. Terminated |
FPA | None listed |
| Feb 16, 2011 | Churchill Medical Systems, Inc. Churchill Medical 78" Stopcock Extension Set with male/female red cap;
item # AMS-464-1
Intended use: Intravascular Administration Set Terminated |
FPA | None listed |
| Feb 16, 2011 | Churchill 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 |
FPA | None listed |
| Feb 16, 2011 | Churchill Medical Systems, Inc. Churchill Medical Systems 14"Extension Set with SmartSite Injection
Item # 43000E
Intended use: Intravascular Administration Set Terminated |
FPA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.