Company ยท US
Churchill Medical Systems, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1988 to 2004. Name variants (Inc, Corp, punctuation) are merged.
12510(k) clearances (0 in 12 months)
36recalls (0 in 12 months)
33recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 21, 2004 | K041038 | CHURCHILL MEDICAL DUAL CHAMBER EMPTY CONTAINER Churchill Medical Systems, Inc. | KPE |
| May 13, 2002 | K021395 | MODIFICATION TO 30 EXTENSION SET Churchill Medical Systems, Inc. | FPA |
| Mar 27, 2002 | K013949 | UNIVERSAL VIAL ACCESS SPIKE WITH NEEDLELESS CONNECTOR Churchill Medical Systems, Inc. | FPA |
| Mar 12, 2002 | K020544 | WING SAFE INFUSION SET 20 GA, SHS2000 SERIES; WING SAFE INFUSION SET 19 GA, SHS1900 SERIES; WING SAFE INFUSION SET 22 GA Churchill Medical Systems, Inc. | FPA |
| Jan 10, 2002 | K013950 | VENTED VIAL ACCESS DEVICE Churchill Medical Systems, Inc. | FPA |
| Sep 11, 2001 | K012157 | CHURCHILL MEDICAL SYSTEMS STOPCOCK Churchill Medical Systems, Inc. | FMG |
| Sep 10, 2001 | K011888 | PRESSURE ACTIVATED CHECK VALVE Churchill Medical Systems, Inc. | FPA |
| Jun 12, 2001 | K011336 | PRIMARY SOLUTION SET WITH UNIVERSAL SPIKE, INJECTION SITE AND MALE LUER LOCK Churchill Medical Systems, Inc. | FPA |
| Jan 11, 1990 | K896333 | CMS IV FILTERS Churchill Medical Systems, Inc. | FPB |
| Nov 13, 1989 | K894954 | .22 & 1.2 MICRON IV FILTERS Churchill Medical Systems, Inc. | FPB |
| Nov 7, 1988 | K884370 | CMS IV EXTENSION SETS Churchill Medical Systems, Inc. | FPK |
| Aug 25, 1988 | K882503 | 30 IV EXTENSION SET W/TWO MALE LUER LOCKS Churchill Medical Systems, Inc. | FPA |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 | K021395 K070705 +1 |
| 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 | K021395 K070705 +1 |
| 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 | K021395 K070705 +1 |
| 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 | K021395 K070705 +1 |
| 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 | K021395 K070705 +1 |
| 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 | K021395 K070705 +1 |
| 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 | K021395 K070705 +1 |
| 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 | K021395 K070705 +1 |
| 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 | K021395 K070705 +1 |
| 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 | K021395 K070705 +1 |
| Apr 21, 2015 | Churchill Medical Systems, Inc. Bifircated Extension Set, Product Code: BN-828
Accessory device used to administer medical fluids Terminated |
FPA | K021395 K070705 +1 |
| 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 | K021395 K070705 +1 |
| Jan 23, 2014 | Churchill Medical Systems, Inc. AMS-530 7 Microbore Trifurcated Extension sets
Product Usage: Intravascular administration set. Terminated |
FPA | K021395 |
| Sep 18, 2013 | Churchill Medical Systems, Inc. Central Dressing Change Kit; AMS-8464CP- 6. Vygon Central Dressing Change Kit contains: 1 Pair Nitrile Gloves W/Wallet, Powderfree 1 Face Mask 1 Polylined Drape, 13" X 18" 1 ChloraPrep***, 3ml Appli Terminated |
FPA | K963981 |
| Sep 18, 2013 | Churchill Medical Systems, Inc. Vygon 14 Microbore Extension Set with Bionector, CMS-814-1. The CMS-814-1 is a 14 inch extension set used to administer IV fluids. Terminated |
FPA | K963981 |
| Mar 6, 2013 | Churchill Medical Systems, Inc. Lifeguard Infusion Set with Smartsite, 20Ga, 1, CLGY-2010
Huber type needle set used for the infusion of medical fluids into implantable ports. Terminated |
FPA | K013871 |
| May 1, 2012 | Churchill Medical Systems, Inc. Churchill Medical Systems Winged Infusion Set, 22Ga, 1",
Latex-Free Winged Infusion Set
Product Code: MBS-2210
Huber type needle set used for the infusion of medical fluids into implantable ports. Terminated |
FMI | K873957 |
| Aug 22, 2011 | Churchill Medical Systems, Inc. Churchill Medical Latex-Free IV Start Kit
Product Code: AMS-623ATLF
The kit includes a tourniquet, alcohol prep pads, a PVP ampule swab, 1 3M" Transpore tape roll, 2 gauze sponges, a 3M" Tegaderm" dr Terminated |
LRS | None listed |
| Feb 16, 2011 | Churchill Medical Systems, Inc. Winged Infusion Set with 90 degree Huber Needle and Y Injection Site
Distributed By: FloridaInfustion Services, Inc., Palm Harbor, FL 34683
Item # FIY-2210
Intended use: Intravascular Administratio Terminated |
FPA | K020544 |
| Feb 16, 2011 | Churchill Medical Systems, Inc. FMI 105"Oral Surgery Administration Set;
Item AMS-468-1
Manufactured For: First Medical inc., 8515 Douglas Ave., Suite 23 Urbandale, IA 50322
Intended use: Intravascular Administration Set Terminated |
FPA | K011336 |
| Feb 16, 2011 | Churchill Medical Systems, Inc. Churchill Medical Systems Central Line and Port Dressing Kit; Item AMS-8295CP-1
Intended use: Intravascular Administration Set 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 | K021395 |
| Feb 16, 2011 | Churchill Medical Systems, Inc. Churchill Medical Systems Fluid Transfer Set; Sterile
Item # AMS-451
Intended use: Intravascular Administration Set Terminated |
FPA | K011336 |
| Feb 16, 2011 | Churchill Medical Systems, Inc. Walkmed Infusion Triton 100" 20 Drop IV Administration Set with Free Flow Protection Clip; Manufactured for: WalkMed Infusion 96 Inverness Drive East, Suite 1 Englewood, CO 80112
Item # T100-000F
Int Terminated |
FPA | K011336 |
| Feb 16, 2011 | Churchill Medical Systems, Inc. Churchill Medical Systems LifeGuard Non-Coring Huber Needle, Lifeguard Non-Coring Safety Infusion Set 22GA, 3/4"; Item # CLG-2234
The Lifeguard Terminated |
FPA | K013871 |
| 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 | K021395 |
| 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 | K021395 |
| Feb 16, 2011 | Churchill Medical Systems, Inc. WalkMed Infusion 100" 20 drop IV Administration Set with 1 Needlefree Y-site and Free Flow Protection Clip
Manufactured for WalkMed Infusion 96 Inverness Drive East Suite 1 Engelwood, CO 80112
Item # Terminated |
FPA | K011336 |
| Feb 16, 2011 | Churchill Medical Systems, Inc. Churchill Medical Systems Central Line Dressing Kit;
Item # AMS-8316CP-1
Intended use: Intravascular Administration Set Terminated |
FPA | None listed |
| Feb 16, 2011 | Churchill Medical Systems, Inc. WalkMed Infusion Triton 90" 20 drop IV Administration Set;
Manufactured for Walked Infusion 96 Inverness Drive East, Suite 14 Englewood, CO 80112
Item # T090-000
Intended use: Intravascular Administ Terminated |
FPA | K011336 |
| Feb 16, 2011 | Churchill Medical Systems, Inc. WalkMed Infusion Triton 90" 20 drop IV Administration Set with Needlefree Y-site and 0.22
Intended use: Intravascular Administration Set Terminated |
FPA | K011336 |
| Feb 16, 2011 | Churchill Medical Systems, Inc. WalkMed Infusion Triton 90" 20 drop IV Administration Set with Needlefree Y-site
Item # T090-000V
Intended use: Intravascular Administration Set Terminated |
FPA | K011336 |
| Feb 16, 2011 | Churchill Medical Systems, Inc. WalkMed Infusion Triton 90" 20 drop IV Administration Set with 2 Needlefree Y-sites and Back Check Valve; Item # T090-000W
Intended use: Intravascular Administration Set Terminated |
FPA | K011336 |
| May 21, 2010 | Churchill Medical Systems, Inc. Churchill Medical Systems Bag Access Device w/Smartsite Needleless Injection Site, Sterile, Non pyrogenic, Latex Free Product Code: KSA-140. Churchill Medical Systems, Inc. Dover, NH 03820.
Intrava Terminated |
FPA | K011336 |
| Mar 24, 2010 | Churchill Medical Systems, Inc. Vygon Nutrisafe 2 syringe 10 ml, Syringe for connection to Nutrisafe 2. For oral use only
Product Code: 1015.122M
Vygon/Churchill Medical System Terminated |
KNT | K060944 K991918 |
| Mar 24, 2010 | Churchill Medical Systems, Inc. Vygon Nutrisafe 2 syringe 5 ml, For Oral use only with Nutrisafe 2
Product Code: 1015.062M
Vygon/Churchill Medical System Terminated |
KNT | K060944 K991918 |