Class Class II

MC2™ Two-Stage Venous Cannula; MC2X™ Three-Stage Venous Cannula (K251258)

K251258 2025-06-20 Traditional
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Description

MC2™ Two-Stage Venous Cannula; MC2X™ Three-Stage Venous Cannula by Medtronic, Inc., an FDA 510(k) cleared cardiovascular device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK251258
Clearance Date2025-06-20
Clearance TypeTraditional
Product CodeDWF
Regulation Number870.4210

Categories

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Predicate lineage for K251258

A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. MC2™ Two-Stage Venous Cannula; MC2X™ Three-Stage Venous Cannula (K251258) cites 1 predicate device and is itself cited by 0 later devices.

Predicate devices cited by this clearance

Devices this clearance was compared against
K numberDeviceApplicantYear
K140165MC2 TWO-STAGE VENOUS CANNULA, OVAL MC2 TWO-STAGE VENOUS CAN...Medtronic, Inc.2014

Trace the full predicate network for K251258

A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.

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