510(k) Report

Devices descending from K971034

38 later devices reach Usci Mainstay Guiding Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K042553Biocardia Morph Universal Deflectable Guide CatheterBiocardia, Inc.20053—
+1K012749Biocardia Universal Deflectable Guide Catheter, Model 000664Biocardia, Inc.200237—
+2K192774BioCardia 8F Morph DNA Deflectable Guide CatheterBiocardia20201—
+2K090999Biocardia Morph Sheath GuideBiocardia, Inc.200903
+2K040922Venture Wire Control CatheterVelocimed, Inc.200431Class I
+2K030630Edwards Directional CatheterEdwards Lifesciences, LLC20030—
+3K242169Morph DNA Steerable Introducer SheathBiocardia20240—
+3K171335Venture 038 catheterVascular Solutions, Inc.20170—
+3K042910Venture Wire Control Catheter, Model WCCVelocimed, Inc.200430Class I
+4K182570Venture 0.014 CatheterVascular Solutions, LLC20192—
+4K061843Venture Wire Control Catheter, Model WCCSt Jude Medical200628Class I
+5K223728Micro RxImds Operations B.V.20231—
+5K080987Bridgepoint Medical Stingray Device and AccessoriesBridgepoint Medical2009241
+6K241611ShapeIT (SI014135)Imds Operations B.V.20240—
+6K121763Multicross Support CatheterRoxwood Medical, Inc.20128—
+6K111963Bridgepoint Medical Mantaray (TM) CatheterBridgepoint Medical20117—
+6K102725Crossboss Catheter Model M-2000, Stingray Orienting Balloon Catheter Model M-1000…Bridge Medical, Inc.2011111
+6K101591Stingray Orienting Balloon CatheterBridgepoint Medical2010141
+7K193322NovaCross CTO MicrocatheterNitiloop, Ltd.20200—
+7K152957MultiCross CatheterRoxwood Medical, Inc.20160—
+7K152401Stingray LP CatheterBoston Scientific Corporation20151—
+7K143608NovaCross MicrocatheterNitiloop, Ltd.20152—
+7K140910Centercross CatheterRoxwood Medical, Inc.20143—
+7K134031Threader Monorail Micro-Dilatation Catheter, Threader Over-the-Wire Micro-Dilatation…Boston Scientific Corporation20140—
+7K122795Stingray GuidewiresBridgepoint Medical201201
+7K120533Bigboss Catheters Mantatay Catheter Mantaray GuidewiresBridgepoint Medical20125—
+7K120129Mantaray CatheterBridgepoint Medical20126—
+8K231176Stingray LP CatheterBoston Scientific20230—
+8K221163Tunnel Crossing CatheterTractus Vascular, LLC20230—
+8K193596Wingman 14, Wingman 14C, Wingman 18, Wingman 35Reflow Medical20201—
+8K183357XableCath Crossing CatheterXablecath, Inc.20190—
+8K172297NovaCross MicrocatheterNitiloop, Ltd.20170—
+8K160389NovaCross MicrocatheterNitiloop, Ltd.20161—
+8K152456CenterCross Ultra CatheterRoxwood Medical, Inc.20162—
+8K121745Mantaray GuidewiresBridgepoint Medical20120—
+9K262013Kiba CTO Crossing CatheterReflow Medical, Inc.20260—
+9K160681CenterCross Ultra CatheterRoxwood Medical, Inc.20161—
+10K170403CenterCross Ultra LV CatheterRoxwood Medical, Inc.20170—