Atlas FDA

TUBING, CONMNECTORS, AND ACCESSORIES WIT BALANCE BIOSURFACE

FDA 510(k) clearance K113845 · decided 2012-01-25

Clearance details

K-number
K113845
Device name
TUBING, CONMNECTORS, AND ACCESSORIES WIT BALANCE BIOSURFACE
Applicant
Medtronic, Inc.
Decision
Substantially Equivalent
Date received
2011-12-28
Decision date
2012-01-25
Days to decision
28 days
Clearance type
Special
Product code
DTL
Device class
2
Regulation number
870.4290
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Minneapolis, MN, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

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RecordFirmDate
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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
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
GUARDIAN II NC HEMOSTASIS VALVE (K101113)Zerusa Limited2010-05-21

Recalls involving this device

RecordFirmDate
Medtronic Intersept Custom Tubing Pack with or without coating ( Carmeda BioActive Surfact recall (Z-0618-2013)Medtronic Inc. Cardiac Rhythm Disease Management2012-12-28

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