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Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Advanced Cardiovascular Systems, Inc. — Predicate Candidate Screening

103 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

81 daysmedian FDA review time
144 days90th percentile
103clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K012534HI-TORQUE MIDDLE SUPPORT .012 GUIDE WIRE WITH HYDROCOAT HYDRAdvanced Cardiovascular Systems, Inc.2002-01-241710
K000550OTW MEGALINK SDS BILIARY STENT SYSTEMAdvanced Cardiovascular Systems, Inc.2000-03-17280
K994229VERIPATH PERIPHERAL GUIDING CATHETERAdvanced Cardiovascular Systems, Inc.2000-02-25710
K992169ACS HI-TORQUE CROSS-IT 400XT GUIDE WIREAdvanced Cardiovascular Systems, Inc.1999-10-281220
K990867RX HERCULINK 14 BILIARY STENT SYSTEM, MODEL 1005126-18,10051Advanced Cardiovascular Systems, Inc.1999-09-021700
K963702ACS HI-TORQUE IRON MAN GUIDE WIREAdvanced Cardiovascular Systems, Inc.1997-01-221280
K962495INDEFLATOR PLUS 30/PLUS 30 PRIORITY PACK9WITH THE.096 OR.115Advanced Cardiovascular Systems, Inc.1996-09-12780
K961471INDEFLATOR 20/30 INFLATION DEVICE AND 20/30 PRIORITY PACK (WAdvanced Cardiovascular Systems, Inc.1996-05-08214
K955175ACS ANCHOR EXCHANGE DEVICEAdvanced Cardiovascular Systems, Inc.1996-04-051440
K953987ACS TOURGIDE GUIDING CATHETERAdvanced Cardiovascular Systems, Inc.1995-12-071060
K952205ACS POWERBASE GUILDING CATHETERAdvanced Cardiovascular Systems, Inc.1995-08-04860
K950752ACS TORQUE DEVICE, ACS GUIDE WIRE INTRODUCER, ACS GUIDE WIREAdvanced Cardiovascular Systems, Inc.1995-05-15871
K950156ACS HI-TORQUE EXTRA S'PORT(TM) GUIDE WIREAdvanced Cardiovascular Systems, Inc.1995-04-05780
K946029ACS GUIDE WIRES WITH MODIFIED PACKAGE INSERTAdvanced Cardiovascular Systems, Inc.1995-02-24770
K942066ACS HI-TORQUE EXTRA S'PORT GUIDE WIREAdvanced Cardiovascular Systems, Inc.1994-07-18800
K940559ACS POWERBASE(TM) CORONARY GUIDING CATHETERAdvanced Cardiovascular Systems, Inc.1994-05-03850
K934624ACS ROTATING HEMOSTATIC VALVE & ACS DUOSTAT ROTATING HEMOSTAAdvanced Cardiovascular Systems, Inc.1994-04-131981
K934009ACS POWERGUIDE CORONARY GUIDING CATHETERAdvanced Cardiovascular Systems, Inc.1994-01-111460
K934602ACS.018 HI-TORQUE FLOPPY GUIDE WIRE - ACS HI-TORQUE FLOPPY EAdvanced Cardiovascular Systems, Inc.1993-12-16830
K934339LOC GUIDE WIRE EXTENSIONAdvanced Cardiovascular Systems, Inc.1993-12-09930
K931171DOC-TITE(TM) GUIDE WIRE EXTENSIONAdvanced Cardiovascular Systems, Inc.1993-06-04880
K914751SELECTIVE INFUSION II CATHETERAdvanced Cardiovascular Systems, Inc.1993-05-245800
K926421ACS ET HI-FLOW/ENHANCED TORQUE CORONARY GUID CATHAdvanced Cardiovascular Systems, Inc.1993-03-23900
K925381ACS HI-TORQUE BALANCE(TM) GUIDE WIREAdvanced Cardiovascular Systems, Inc.1993-02-121120
K921719ACS ANGIOTRAK(TM) SYSTEMAdvanced Cardiovascular Systems, Inc.1992-08-071200
K915723.10' HI-TORQUE FLOPPY, INTER. & STAND. GUIDE WIREAdvanced Cardiovascular Systems, Inc.1992-06-091720
K914828010 HI-TOR INTER/STAND GUIDWIRE PRESHAPE TIP/MODIFAdvanced Cardiovascular Systems, Inc.1992-01-08760
K913631.014 HI-TORQUE FLOPPY PATHFINDER GUIDE WIREAdvanced Cardiovascular Systems, Inc.1991-10-28740
K913328.010 HI-TORQUE PLUS(TM) GUIDE WIREAdvanced Cardiovascular Systems, Inc.1991-10-23900
K913353VASCULAR GUIDE WIREAdvanced Cardiovascular Systems, Inc.1991-10-23890
K913178ACS VSW GUIDE WIREAdvanced Cardiovascular Systems, Inc.1991-10-08830
K911957ACS RX SUPPORT CATHETERAdvanced Cardiovascular Systems, Inc.1991-09-061270
K911460.010 HI-TORQUE GUIDE WIRES WITH PRESHAPED TIPAdvanced Cardiovascular Systems, Inc.1991-06-25830
K905715ACS ANGIOSCOPIC CATHETERAdvanced Cardiovascular Systems, Inc.1991-03-18870
K905502.010 HI-TORQUE FLOPPY GUIDE WIRE W/PRESHAPED TIPAdvanced Cardiovascular Systems, Inc.1991-02-04590
K904884ACS URETHAN CORONARY GUIDING CATHETERAdvanced Cardiovascular Systems, Inc.1991-01-03690
K902755.018 HI-TORQUE FLOPPY GUIDE WIRE W/ PRESHAPED TIPAdvanced Cardiovascular Systems, Inc.1990-09-04740
K902207ACS .010 HI-TORQUE INTER. AND STANDARD GUIDE WIREAdvanced Cardiovascular Systems, Inc.1990-08-08840
K900386ACS ADVANCED CONCEPT GUIDE WIREAdvanced Cardiovascular Systems, Inc.1990-06-121340
K896849ACS INDEFLATOR XXAdvanced Cardiovascular Systems, Inc.1990-02-28850
K896379ACS GOLD SERIES ELASTINITE GUIDE WIREAdvanced Cardiovascular Systems, Inc.1990-02-02880
K882507ACS 0.015 & 0.018 PRESSURE GUIDE WIRE W/MICRO.Advanced Cardiovascular Systems, Inc.1989-03-312870
K885237ACS SELECTIVE INFUSION CATHETERAdvanced Cardiovascular Systems, Inc.1989-03-16850
K884895ACS 0.010 HI-TORQUE FLOPPY GOLD GUIDE WIREAdvanced Cardiovascular Systems, Inc.1989-02-06760
K884262ACS(R) HI-TORQUE GOLD(TM) GUIDE WIREAdvanced Cardiovascular Systems, Inc.1988-12-21710
K883564ACS SOFT-TIP CORONARY INFUSION CATH W/SIDE HOLESAdvanced Cardiovascular Systems, Inc.1988-11-03730
K883452ACS INDEFLATOR P/T 20Advanced Cardiovascular Systems, Inc.1988-10-14630
K883000ACS ANGIOSCOPE GUIDE WIREAdvanced Cardiovascular Systems, Inc.1988-09-28720
K882925ACS SCHWARTEN XT BALLOON DILATATION CATHETERAdvanced Cardiovascular Systems, Inc.1988-09-28770
K882928TAD INTERMEDIATE & TAD STANDARD GUIDE WIREAdvanced Cardiovascular Systems, Inc.1988-09-27810

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda