Atlas FDA

MODIFICATION TO 30 EXTENSION SET

FDA 510(k) clearance K021395 · decided 2002-05-13

Clearance details

K-number
K021395
Device name
MODIFICATION TO 30 EXTENSION SET
Applicant
Churchill Medical Systems, Inc.
Decision
Substantially Equivalent
Date received
2002-05-02
Decision date
2002-05-13
Days to decision
11 days
Clearance type
Special
Product code
FPA
Device class
2
Regulation number
880.5440
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
Dover, NH, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
6" Trifurcated Extension Set, Product Code: AMS-375-1 Accessory device used to administer recall (Z-1467-2015)Churchill Medical Systems, Inc.2015-04-21
Bifircated Extension Set, Product Code: BN-828 Accessory device used to administer medical recall (Z-1468-2015)Churchill Medical Systems, Inc.2015-04-21
4" Microbore Double Lumen Set with Bionector, Product Code: BN-208 Accessory device used t recall (Z-1469-2015)Churchill Medical Systems, Inc.2015-04-21
4" Microbore Trifurcated Ext set, Product Code: BN-308 Accessory device used to administer recall (Z-1470-2015)Churchill Medical Systems, Inc.2015-04-21
4" Microbore T-Port Set, Product Code: BN-448 Accessory device used to administer medical recall (Z-1471-2015)Churchill Medical Systems, Inc.2015-04-21
8" Standard Bore Ext Set, Product Code: BN-481 Accessory device used to administer medical recall (Z-1472-2015)Churchill Medical Systems, Inc.2015-04-21
7" High Pressure Set with Bionector, Product Code: CMS-808 and CMS-808-1 Accessory device recall (Z-1473-2015)Churchill Medical Systems, Inc.2015-04-21
7" Standard Bore High Pressure Ext Set, Product Code: CMS-809 Accessory device used to adm recall (Z-1474-2015)Churchill Medical Systems, Inc.2015-04-21
7" Standard Bore High Pressure Ext Set, Product Code: CMS-809 Accessory device used to adm recall (Z-1475-2015)Churchill Medical Systems, Inc.2015-04-21
Bifurcated set with check vales and Bionectors, Product Code: BN-2082CV Accessory device u recall (Z-1476-2015)Churchill Medical Systems, Inc.2015-04-21
4" Trifurcated set with Bionectors and check valves, Product Code: BN-3082CV and BN-3083CV recall (Z-1477-2015)Churchill Medical Systems, Inc.2015-04-21
6" Trifurcated set with Bionectors, Product Code: BN-944 Accessory device used to administ recall (Z-1478-2015)Churchill Medical Systems, Inc.2015-04-21
AMS-530 7 Microbore Trifurcated Extension sets Product Usage: Intravascular administration recall (Z-0813-2014)Churchill Medical Systems, Inc.2014-01-23
Churchill Medical 78" Stopcock Extension Set with male/female red cap; item # AMS-464-1 In recall (Z-1325-2011)Churchill Medical Systems, Inc.2011-02-16
Churchill Medical Systems 6" Microbore Trifurcated non-DEHP Extension Set with male/Female recall (Z-1326-2011)Churchill Medical Systems, Inc.2011-02-16
Churchill Medical Systems 14"Extension Set with SmartSite Injection Item # 43000E Intended recall (Z-1330-2011)Churchill Medical Systems, Inc.2011-02-16