Atlas FDA

MX 339 TWIN HEMOSTATIC Y CONNECTOR

FDA 510(k) clearance K912709 · decided 1991-09-11

Clearance details

K-number
K912709
Device name
MX 339 TWIN HEMOSTATIC Y CONNECTOR
Applicant
Medex, Inc.
Decision
Substantially Equivalent
Date received
1991-06-19
Decision date
1991-09-11
Days to decision
84 days
Clearance type
Traditional
Product code
DTL
Device class
2
Regulation number
870.4290
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Hilliard, OH, US
Third-party review
No
Expedited review
No

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RecordFirmDate
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COLIGN (K131124)Jilin Coronado Medical , Ltd.2013-08-28
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CONNECTOR COMPONENTS WITH BALANCE BIOSURFACE (K122811)Medtronic, Inc.2012-10-12
GUARDIAN II HEMOSTASIS VALVE GUARDIAN II NC HEMOSTASIS VALVE (K122301)Vascular Solutions Zerusa , Ltd.2012-09-07
MEDLINE STOPCOCK AND MANIFOLD (K120069)Medline Industries, Inc.2012-04-03
E-PASS (K113148)Synexmed(Shenzhen)Company Limited2012-02-28
TUBING, CONMNECTORS, AND ACCESSORIES WIT BALANCE BIOSURFACE (K113845)Medtronic, Inc.2012-01-25
DISPOSABLE HEMOSTATIC Y-CONNECTORS (K113132)Coeur, Inc.2012-01-20
CARDIOPLEGIA DELIVERY SETS CARDIOPLEGIA DELIVERY SETS WITH DURAFLO COATING (K113667)Edwards Lifesciences, LLC2012-01-12

Recalls involving this device

No recalls on record reference this clearance.