# Advanced Cardiovascular Systems, Inc.

- Location (FDA's records): Santa Clara, CA
- FDA decisions: 104 (1982–2002): 103 510(k) clearances and 1 original PMA approval
- Product codes: DQX (45), DQY (19), LIT (10), DQO (6), DXT (4), DYB (4), MAV (4), LOX (3), FGE (2), LYK (2), DQT (1), KRA (1)
- Predicates its devices cite: 9 (5 its own); citations of its devices by later devices: 69 (5 its own)
- Recalls linked to its devices: 18 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Guidant Corp.: 1 (https://510kreport.com/company/guidant)
- Johnson & Johnson Interventional Systems: 1 (https://510kreport.com/company/johnson-johnson-interventional-systems)
- Baxter Healthcare Corp: 1 (https://510kreport.com/company/baxter-healthcare)
- Boston Scientific Corp: 1 (https://510kreport.com/company/boston-scientific)

## Firms that cite its devices most
- B.Braun Medical, Inc.: 23 (https://510kreport.com/company/b-braun-medical)
- Guidant Corp.: 18 (https://510kreport.com/company/guidant)
- Brosmed Medical Co., Ltd.: 3 (https://510kreport.com/company/brosmed-medical)
- Cordis Corp.: 3 (https://510kreport.com/company/cordis)
- Intra Luminal Therapeutics, Inc.: 2 (https://510kreport.com/company/intra-luminal-therapeutics)
- Orbusneich Medical, Inc.: 2 (https://510kreport.com/company/orbusneich-medical)
- Js Vascular, Inc.: 2 (https://510kreport.com/company/js-vascular)
- Cardionet, Inc.: 1 (https://510kreport.com/company/cardionet)

## Its most-cited devices
- P810046: Simpson-Robert Coronary Balloon Dilatation Cathete (1982), cited by 5
- K881897: Acs HI-Torque Floppy/Floppy II/Inter./Standard GW (1988), cited by 4
- K950156: Acs HI-Torque Extra S'port (TM) Guide Wire (1995), cited by 4
- K942066: Acs HI-Torque Extra S'port Guide Wire (1994), cited by 4
- K861765: Acs Wholey HI-Torque Guide Wire (1986), cited by 4
- K925381: Acs HI-Torque Balance (TM) Guide Wire (1993), cited by 4

## Recent decisions
- K012534: HI-Torque Middle Support .012 Guide Wire with Hydrocoat Hydrophilic Coating (Jan 24, 2002)
- K000550: Otw Megalink SDS Biliary Stent System (Mar 17, 2000)
- K994229: Veripath Peripheral Guiding Catheter (Feb 25, 2000)
- K992169: Acs HI-Torque Cross-IT 400XT Guide Wire (Oct 28, 1999)
- K990867: RX Herculink 14 Biliary Stent System, Model 1005126-18,1005128-18,1005130-18,1005132-18,1005134-18,1005136-18,1005138-18 (Sep 2, 1999)
- K963702: Acs HI-Torque Iron Man Guide Wire (Jan 22, 1997)
- K962495: Indeflator Plus 30/Plus 30 Priority PACK9WITH the.096 or.115 Rotating Hemostatic Valve) (Sep 12, 1996)
- K961471: Indeflator 20/30 Inflation Device and 20/30 Priority Pack (with the .096 or .115 Rotating Hemostatic Valve) (May 8, 1996)

Source page: https://510kreport.com/company/advanced-cardiovascular-systems