510(k) Report

Devices descending from K133177

28 later devices reach Modified HD Guide Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K242301Socrates 38 CatheterScientia Vascular, Inc.20240—
+1K151667AXS Catalyst Distal Access Catheter 058x115cm, AXS Catalyst Distal Access Catheter…Stryker2015263
+2K234115APRO 55 CatheterAlembic, LLC20244—
+2K233205Distal Access CatheterShanghai Heartcare Medical Technology Co., Ltd.20230—
+2K183463AXS Catalyst Distal Access Catheter 068 x 115cm, AXS Catalyst Distal Access Catheter 068…Stryker201914—
+2K182097React 71 CatheterMicro Therapeutics, Inc. d/b/a ev3 Neurovascular20182—
+2K180715React 68 CatheterMicro Therapeutics, Inc. d/b/a ev3 Neurovascular201819—
+3K251097V-DAC CatheterVesalio, Inc.20260—
+3K251014APRO 45 CatheterAlembic, LLC20251—
+3K250962APRO 55 Intermediate CatheterAlembic, LLC20250—
+3K243297APRO 70 Swift CatheterAlembic, LLC20250—
+3K241177React 71 CatheterMicro Therapeutics Lnc. D/B/A Ev3 Neurovascular20240—
+3K231056Esperance Distal Access CatheterWallaby Medical20240—
+3K220716Spartan SC 069Spartan Micro, Inc.20220—
+3K190833AXS Vecta Aspiration CatheterStryker Neurovascular20196—
+3K191237CERENOVUS Large Bore CatheterCodman & Shurtleff, Inc.20195—
+4K262392APRO 35 Swift CatheterAlembic, LLC20260—
+4K221930CEREGLIDE 71 Intermediate CatheterCerenovus, Inc.20231—
+4K202752AXS Vecta 46 Intermediate CatheterStryker Neurovascular20213—
+4K193380CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing SetCodman & Shurtleff, Inc.20203—
+4K200206AXS Vecta 71 Intermediate Catheter, AXS Vecta 74 Intermediate CatheterStryker Neurovascular20201—
+5K261176Zoom 4S CatheterImperative Care, Inc.20260—
+5K251828CEREGLIDE 71 Catheter System; Cerenovus Aspiration Tubing SetCerenovus, Inc.20250—
+5K241768Broadway 8 CatheterStryker Neurovascular20240—
+5K241244CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediate CatheterCerenovus, Inc.20241—
+5K233988Cerenovus Large Bore Catheter; Cerenovus Aspiration Tubing SetCerenovus, Inc.20240—
+5K221934CEREGLIDE 71 Intermediate Catheter; Cerenovus Aspiration Tubing SetCerenovus, Inc.20231—
+6K262398CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing setCERENOVUS, Inc.20260—