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510(k) K122576 · MJN Catheter, Intravascular Occluding, Temporary

TRANSFORM OCCLUSION BALLOON CATHETER (COMPLIANT AND SUPER COMPLIANT

Applicant	Stryker Neurovascular, Fremont CA, US
Decision	Substantially Equivalent, Jan 11, 2013
Received	Aug 23, 2012
Type	Traditional
FDA record	Open on fda.gov

Recalls that name K122576

Date	Firm and product	Code	Linked 510(k)
Dec 13, 2013	Stryker Neurovascular Stryker brand COMPLIANT 4MM X 10MM, Catalog Number: M003SRC04100; Product is manufactured by Stryker Neurovascular, Cork, Ireland and distributed by Stryker Neurovascular, Fremont, CA Excelsior SL-10 Terminated	MJN	None listed
Dec 13, 2013	Stryker Neurovascular Stryker brand COMPLIANT 4MM X 15MM, Catalog Number: M003SRC04150; Product is manufactured by Stryker Neurovascular, Cork, Ireland and distributed by Excelsior SL-10/Excelsior 1018 Microcatheter: Stryk Terminated	MJN	None listed
Dec 13, 2013	Stryker Neurovascular Stryker brand COMPLIANT 4MM X 20MM, Catalog Number: M003SRC04200; Product is manufactured by Stryker Neurovascular, Cork, Ireland and distributed by Stryker Neurovascular, Fremont, CA Excelsior SL-10 Terminated	MJN	None listed
Dec 13, 2013	Stryker Neurovascular Stryker brand COMPLIANT 4MM X 30MM, Catalog Number: M003SRC04300; Product is manufactured by Stryker Neurovascular, Cork, Ireland and distributed by Stryker Neurovascular, Fremont, CA Excelsior SL-10 Terminated	MJN	None listed
Dec 13, 2013	Stryker Neurovascular Stryker brand COMPLIANT 5MM X 15MM, Catalog Number: M003SRC05150; Product is manufactured by Stryker Neurovascular, Cork, Ireland and distributed by Stryker Neurovascular, Fremont, CA Excelsior SL Terminated	MJN	None listed
Dec 13, 2013	Stryker Neurovascular Stryker brand COMPLIANT 5MM X 30MM, Catalog Number: M003SRC05300; Product is manufactured by Stryker Neurovascular, Cork, Ireland and distributed by Stryker Neurovascular, Fremont, CA Excelsior SL-1 Terminated	MJN	None listed
Dec 13, 2013	Stryker Neurovascular Stryker brand SUPER COMPLIANT 4MM X 7MM, Catalog Number: M003SSC04070; Product is manufactured by Stryker Neurovascular, Cork, Ireland and distributed by Stryker Neurovascular, Fremont, CA Excelsior Terminated	MJN	None listed
Dec 13, 2013	Stryker Neurovascular Stryker brand SUPER COMPLIANT 7MM X 15MM, Catalog Number: M003SSC07150; Product is manufactured by Stryker Neurovascular, Cork, Ireland and distributed by Stryker Neurovascular, Fremont, CA Excelsio Terminated	MJN	None listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.