ClearanceBrief
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

CodeDeviceRecords
FPASet, Administration, Intravascular39
FPBFilter, Infusion Line2
KNTTubes, Gastrointestinal (And Accessories)2
FMGStopcock, I.V. Set1
FMINeedle, Hypodermic, Single Lumen1
FPKTubing, Fluid Delivery1
KPEContainer, I.V.1
LRSI.V. Start Kit1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Dec 21, 2004K041038CHURCHILL MEDICAL DUAL CHAMBER EMPTY CONTAINER
Churchill Medical Systems, Inc.
KPE
May 13, 2002K021395MODIFICATION TO 30 EXTENSION SET
Churchill Medical Systems, Inc.
FPA
Mar 27, 2002K013949UNIVERSAL VIAL ACCESS SPIKE WITH NEEDLELESS CONNECTOR
Churchill Medical Systems, Inc.
FPA
Mar 12, 2002K020544WING 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, 2002K013950VENTED VIAL ACCESS DEVICE
Churchill Medical Systems, Inc.
FPA
Sep 11, 2001K012157CHURCHILL MEDICAL SYSTEMS STOPCOCK
Churchill Medical Systems, Inc.
FMG
Sep 10, 2001K011888PRESSURE ACTIVATED CHECK VALVE
Churchill Medical Systems, Inc.
FPA
Jun 12, 2001K011336PRIMARY SOLUTION SET WITH UNIVERSAL SPIKE, INJECTION SITE AND MALE LUER LOCK
Churchill Medical Systems, Inc.
FPA
Jan 11, 1990K896333CMS IV FILTERS
Churchill Medical Systems, Inc.
FPB
Nov 13, 1989K894954.22 & 1.2 MICRON IV FILTERS
Churchill Medical Systems, Inc.
FPB
Nov 7, 1988K884370CMS IV EXTENSION SETS
Churchill Medical Systems, Inc.
FPK
Aug 25, 1988K88250330 IV EXTENSION SET W/TWO MALE LUER LOCKS
Churchill Medical Systems, Inc.
FPA

Latest recalls

DateFirm and productCodeLinked 510(k)
Apr 21, 2015Churchill Medical Systems, Inc.
6" Trifurcated set with Bionectors, Product Code: BN-944 Accessory device used to administer medical fluids
Terminated
FPAK021395
K070705 +1
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
FPAK021395
K070705 +1
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
FPAK021395
K070705 +1
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
FPAK021395
K070705 +1
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
FPAK021395
K070705 +1
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
FPAK021395
K070705 +1
Apr 21, 2015Churchill Medical Systems, Inc.
8" Standard Bore Ext Set, Product Code: BN-481 Accessory device used to administer medical fluids
Terminated
FPAK021395
K070705 +1
Apr 21, 2015Churchill Medical Systems, Inc.
4" Microbore T-Port Set, Product Code: BN-448 Accessory device used to administer medical fluids
Terminated
FPAK021395
K070705 +1
Apr 21, 2015Churchill Medical Systems, Inc.
4" Microbore Trifurcated Ext set, Product Code: BN-308 Accessory device used to administer medical fluids
Terminated
FPAK021395
K070705 +1
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
FPAK021395
K070705 +1
Apr 21, 2015Churchill Medical Systems, Inc.
Bifircated Extension Set, Product Code: BN-828 Accessory device used to administer medical fluids
Terminated
FPAK021395
K070705 +1
Apr 21, 2015Churchill Medical Systems, Inc.
6" Trifurcated Extension Set, Product Code: AMS-375-1 Accessory device used to administer medical fluids
Terminated
FPAK021395
K070705 +1
Jan 23, 2014Churchill Medical Systems, Inc.
AMS-530 7 Microbore Trifurcated Extension sets Product Usage: Intravascular administration set.
Terminated
FPAK021395
Sep 18, 2013Churchill 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
FPAK963981
Sep 18, 2013Churchill 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
FPAK963981
Mar 6, 2013Churchill 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
FPAK013871
May 1, 2012Churchill 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
FMIK873957
Aug 22, 2011Churchill 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
LRSNone listed
Feb 16, 2011Churchill 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
FPAK020544
Feb 16, 2011Churchill 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
FPAK011336
Feb 16, 2011Churchill Medical Systems, Inc.
Churchill Medical Systems Central Line and Port Dressing Kit; Item AMS-8295CP-1 Intended use: Intravascular Administration Set
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
FPAK021395
Feb 16, 2011Churchill Medical Systems, Inc.
Churchill Medical Systems Fluid Transfer Set; Sterile Item # AMS-451 Intended use: Intravascular Administration Set
Terminated
FPAK011336
Feb 16, 2011Churchill 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
FPAK011336
Feb 16, 2011Churchill 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
FPAK013871
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
FPAK021395
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
FPAK021395
Feb 16, 2011Churchill 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
FPAK011336
Feb 16, 2011Churchill Medical Systems, Inc.
Churchill Medical Systems Central Line Dressing Kit; Item # AMS-8316CP-1 Intended use: Intravascular Administration Set
Terminated
FPANone listed
Feb 16, 2011Churchill 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
FPAK011336
Feb 16, 2011Churchill 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
FPAK011336
Feb 16, 2011Churchill 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
FPAK011336
Feb 16, 2011Churchill 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
FPAK011336
May 21, 2010Churchill 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
FPAK011336
Mar 24, 2010Churchill 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
KNTK060944
K991918
Mar 24, 2010Churchill 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
KNTK060944
K991918
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