Atlas FDA

MODIFICATION TO: LATEX-FREE BIONECTOR, MODEL# 896.019, 896.039

FDA 510(k) clearance K070705 · decided 2007-11-30

Clearance details

K-number
K070705
Device name
MODIFICATION TO: LATEX-FREE BIONECTOR, MODEL# 896.019, 896.039
Applicant
Vygon Corp.
Decision
Substantially Equivalent
Date received
2007-03-14
Decision date
2007-11-30
Days to decision
261 days
Clearance type
Traditional
Product code
FOZ
Device class
2
Regulation number
880.5200
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
Norristown, PA, 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
Bionector Needleless connector. Bionector is a multi-purpose catheter accessory; a closed recall (Z-0113-2015)Vygon Corporation2014-10-22