510(k) Report

FDA applicant

Advanced Cardiovascular Systems, Inc.

Santa Clara, CA104 decisions1982–200218 recalls

FDA records 104 decisions for Advanced Cardiovascular Systems, Inc. (Santa Clara, CA) from 1982 to 2002: 103 510(k) clearances and 1 original PMA approval. Most are in product codes DQX (Wire, Guide, Catheter) and DQY (Catheter, Percutaneous). Its devices cite 9 predicates, 5 of them its own earlier devices. 18 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Advanced Cardiovascular Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Advanced Cardiovascular Systems, Inc. since 2007.

Recalls per year

4in 2024

2009: 42011: 12018: 12022: 52024: 4
2007high 5 (2022) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Advanced Cardiovascular Systems, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Advanced Cardiovascular Systems, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • DQXWire, Guide, Catheter45decisions
  • DQYCatheter, Percutaneous19decisions
  • LITCatheter, Angioplasty, Peripheral, Transluminal10decisions
  • DQOCatheter, Intravascular, Diagnostic6decisions
  • DXTInjector And Syringe, Angiographic4decisions
  • DYBIntroducer, Catheter4decisions

Also: MAV (4), LOX (3), FGE (2), LYK (2), DQT (1), KRA (1).

Whose devices does it build on?

Its devices cite 9 predicates; 5 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 69 times; 5 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • P810046Simpson-Robert Coronary Balloon Dilatation CatheteAdvanced Cardiovascular Systems, Inc. · 19825cite it
  • K881897Acs HI-Torque Floppy/Floppy II/Inter./Standard GWAdvanced Cardiovascular Systems, Inc. · 19884cite it
  • K950156Acs HI-Torque Extra S'port (TM) Guide WireAdvanced Cardiovascular Systems, Inc. · 19954cite it
  • K942066Acs HI-Torque Extra S'port Guide WireAdvanced Cardiovascular Systems, Inc. · 19944cite it
  • K861765Acs Wholey HI-Torque Guide WireAdvanced Cardiovascular Systems, Inc. · 19864cite it
  • K925381Acs HI-Torque Balance (TM) Guide WireAdvanced Cardiovascular Systems, Inc. · 19934cite it

What has FDA decided for it lately?

  • K012534HI-Torque Middle Support .012 Guide Wire with Hydrocoat Hydrophilic CoatingAdvanced Cardiovascular Systems, Inc. · 2002
  • K000550Otw Megalink SDS Biliary Stent SystemAdvanced Cardiovascular Systems, Inc. · 2000
  • K994229Veripath Peripheral Guiding CatheterAdvanced Cardiovascular Systems, Inc. · 2000
  • K992169Acs HI-Torque Cross-IT 400XT Guide WireAdvanced Cardiovascular Systems, Inc. · 1999
  • K990867RX Herculink 14 Biliary Stent System, Model…Advanced Cardiovascular Systems, Inc. · 1999
  • K963702Acs HI-Torque Iron Man Guide WireAdvanced Cardiovascular Systems, Inc. · 1997
  • K962495Indeflator Plus 30/Plus 30 Priority PACK9WITH the.096 or.115 Rotating Hemostatic Valve)Advanced Cardiovascular Systems, Inc. · 19963 recalls
  • K961471Indeflator 20/30 Inflation Device and 20/30 Priority Pack (with the .096 or .115 Rotating Hemostatic Valve)Advanced Cardiovascular Systems, Inc. · 19967 recalls

All 104 as Advanced Cardiovascular Systems, Inc. →

What has been recalled?

18 recalls linked to its devices; the latest:

  • K96147120/30 INDEFLATOR, REF: 1000184, for use during cardiovascular procedures in conjunction…Nov 6, 2024Class II
  • K96147120/30 Priority Pack Accessory Kit/.096 RHV, REF: 1000186, or use during vascular…Nov 6, 2024Class II
  • K96147120/30 Priority Pack Accessory Kit w/Copilot, REF: 1003327, used for cardiovascular…Nov 6, 2024Class II
  • K96147120/30 Priority Pack Kit/.115 RHV, REF: 1000186-115, used for cardiovascular procedures.Nov 6, 2024Class II
  • K96147120/30 Priority Pack Accessory Kit/.096 RHV - REF 1000186 WPL2122270-01 (2019-03-01)…Mar 11, 2022Class II
  • K96147120/30 Priority Pack w/COPILOT - REF 1003327 WPL2122272-01 (2019-03-01)Mar 11, 2022Class II