Advanced Cardiovascular Systems, Inc.
Medical device manufacturer in Santa Clara, CA.
103510(k) clearances
1PMA approvals
0recalls
Device types
- DQX Wire, Guide, Catheter 45
- DQY Catheter, Percutaneous 19
- LIT Catheter, Angioplasty, Peripheral… 10
- DQO Catheter, Intravascular, Diagnostic 6
- DYB Introducer, Catheter 4
- DXT Injector And Syringe, Angiographic 4
- MAV Syringe, Balloon Inflation 4
- LOX Catheters, Transluminal Coronary… 2
- LYK Angioscope 2
- FGE Stents, Drains And Dilators For The Biliary… 2
- DAO Igm (Mu Chain Specific), Antigen… 1
- DQT Occluder, Catheter Tip 1
- DTL Adaptor, Stopcock, Manifold, Fitting… 1
- KRA Catheter, Continuous Flush 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K012534 | Hi-Torque Middle Support .012 Guide Wire with Hydrocoat Hydrophilic CoatingDQX · Traditional | 01/24/2002SE |
| K000550 | Otw Megalink SDS Biliary Stent SystemFGE · Special | 03/17/2000SESU |
| K994229 | Veripath Peripheral Guiding CatheterDQY · Special | 02/25/2000SE |
| K992169 | Acs Hi-Torque Cross-It 400XT Guide WireDQX · Traditional | 10/28/1999SE |
| K990867 | RX Herculink 14 Biliary Stent System, Model 1005126-18,1005128-18,1005130-18,1005132-18,1…FGE · Traditional | 09/02/1999SESU |
| K963702 | Acs Hi-Torque Iron Man Guide WireDQX · Traditional | 01/22/1997SE |
| K962495 | Indeflator Plus 30/PLUS 30 Priority PACK9WITH THE.096 OR.115 Rotating Hemostatic Valve)MAV · Traditional | 09/12/1996SE |
| K961471 | Indeflator 20/30 Inflation Device and 20/30 Priority Pack (with the .096 or .115…MAV · Traditional | 05/08/1996SESK |
| K955175 | Acs Anchor Exchange DeviceDQX · Traditional | 04/05/1996SE |
| K953987 | Acs Tourgide Guiding CatheterDQY · Traditional | 12/07/1995SE |
| K952205 | Acs Powerbase Guilding CatheterDQY · Traditional | 08/04/1995SE |
| K950752 | Acs Torque Device, Acs Guide Wire Introducer, Acs Guide Wire Accessory KitsDQX · Traditional | 05/15/1995SE |
| K950156 | Acs Hi-Torque Extra S'Port(Tm) Guide WireDQX · Traditional | 04/05/1995SE |
| K946029 | Acs Guide Wires with Modified Package InsertDQX · Traditional | 02/24/1995SE |
| K942066 | Acs Hi-Torque Extra S'Port Guide WireDQX · Traditional | 07/18/1994SE |
| K940559 | Acs Powerbase(Tm) Coronary Guiding CatheterDQY · Traditional | 05/03/1994SE |
| K934624 | Acs Rotating Hemostatic Valve & Acs Duostat Rotating Hemostatic ValveDYB · Traditional | 04/13/1994SE |
| K934009 | Acs Powerguide Coronary Guiding CatheterDQY · Traditional | 01/11/1994SE |
| K934602 | ACS.018 Hi-Torque Floppy Guide Wire - Acs Hi-Torque Floppy Extra Support Guide WireDQX · Traditional | 12/16/1993SE |
| K934339 | Loc Guide Wire ExtensionDQX · Traditional | 12/09/1993SE |
| K931171 | Doc-Tite(Tm) Guide Wire ExtensionDQX · Traditional | 06/04/1993SE |
| K914751 | Selective Infusion II CatheterKRA · Traditional | 05/24/1993SE |
| K926421 | Acs Et Hi-Flow/Enhanced Torque Coronary Guid CathDQY · Traditional | 03/23/1993SE |
| K925381 | Acs Hi-Torque Balance(Tm) Guide WireDQX · Traditional | 02/12/1993SE |
| K921719 | Acs Angiotrak(Tm) SystemMAV · Traditional | 08/07/1992SE |
| K915723 | .10' Hi-Torque Floppy, Inter. & Stand. Guide WireDQX · Traditional | 06/09/1992SE |
| K914828 | 010 Hi-Tor Inter/Stand Guidwire Preshape Tip/ModifDQX · Traditional | 01/08/1992SE |
| K913631 | .014 Hi-Torque Floppy Pathfinder Guide WireDQX · Traditional | 10/28/1991SE |
| K913353 | Vascular Guide WireDQX · Traditional | 10/23/1991SE |
| K913328 | .010 Hi-Torque Plus(Tm) Guide WireDQX · Traditional | 10/23/1991SE |
| K913178 | Acs VSW Guide WireDQX · Traditional | 10/08/1991SE |
| K911957 | Acs RX Support CatheterDQO · Traditional | 09/06/1991SE |
| K911460 | .010 Hi-Torque Guide Wires with Preshaped TipDQX · Traditional | 06/25/1991SE |
| K905715 | Acs Angioscopic CatheterDQO · Traditional | 03/18/1991SE |
| K905502 | .010 Hi-Torque Floppy Guide Wire W/Preshaped TipDQX · Traditional | 02/04/1991SE |
| K904884 | Acs Urethan Coronary Guiding CatheterDQY · Traditional | 01/03/1991SE |
| K902755 | .018 Hi-Torque Floppy Guide Wire W/ Preshaped TipDQX · Traditional | 09/04/1990SE |
| K902207 | Acs .010 Hi-Torque Inter. and Standard Guide WireDQX · Traditional | 08/08/1990SE |
| K900386 | Acs Advanced Concept Guide WireDQX · Traditional | 06/12/1990SE |
| K896849 | Acs Indeflator XXMAV · Traditional | 02/28/1990SE |
| K896379 | Acs Gold Series Elastinite Guide WireDQX · Traditional | 02/02/1990SE |
| K882507 | Acs 0.015 & 0.018 Pressure Guide Wire W/Micro.DQX · Traditional | 03/31/1989SE |
| K885237 | Acs Selective Infusion CatheterDQY · Traditional | 03/16/1989SE |
| K884895 | Acs 0.010 Hi-Torque Floppy Gold Guide WireDQX · Traditional | 02/06/1989SE |
| K884262 | Acs(R) Hi-Torque Gold(Tm) Guide WireDQX · Traditional | 12/21/1988SE |
| K883564 | Acs Soft-Tip Coronary Infusion Cath W/Side HolesDQY · Traditional | 11/03/1988SE |
| K883452 | Acs Indeflator P/T 20DXT · Traditional | 10/14/1988SE |
| K883000 | Acs Angioscope Guide WireLYK · Traditional | 09/28/1988SE |
| K882925 | Acs Schwarten XT Balloon Dilatation CatheterLIT · Traditional | 09/28/1988SE |
| K882928 | Tad Intermediate & Tad Standard Guide WireDQX · Traditional | 09/27/1988SE |
| K875108 | Acs Coronary Angioscopic CatheterLYK · Traditional | 09/27/1988SE |
| K882803 | Et Hi-Flow Soft Tip/Et Hi-Flow/Enhanced Torque STDQY · Traditional | 09/16/1988SE |
| K882321 | Acs Deflectable Tip Guide Wire W/Microglide(R)CoatDQX · Traditional | 08/30/1988SE |
| K881897 | Acs Hi-Torque Floppy/Floppy Ii/Inter./Standard GWDQX · Traditional | 08/03/1988SE |
| K881787 | Acs Hi-Torque Standard & Intermedi. Guide WireDQX · Traditional | 07/25/1988SE |
| K875158 | Acs Funnel IntroducerDYB · Traditional | 05/31/1988SE |
| K874202 | Acs Hi-Torque Guide WiresDQX · Traditional | 04/28/1988SE |
| K874874 | Acs Hi-Torque Coronary Guiding Catheter W/Soft TipDQY · Traditional | 02/18/1988SE |
| K874776 | Acs 0.025-IN Hi-Torq Modif J/Stand Telesc GuidewirDQX · Traditional | 02/17/1988SE |
| K875269 | Acs Soft-Tip Coronary Infusion Catheter W/SideholeDQY · Traditional | 02/12/1988SE |
| K872981 | Acs Indeflator Plus (Modification #2)DXT · Traditional | 10/20/1987SE |
| K872220 | Acs Hi-Torque Flex-T Guide Wire (Modification)DQX · Traditional | 08/21/1987SE |
| K871425 | Acs Enhanced-Torque Coronary Guiding CatheterDQY · Traditional | 05/22/1987SE |
| K864585 | Acs Hi-Torque Floppy Guide Wire, 0.018 InchDQX · Traditional | 12/05/1986SE |
| K862360 | Acs Hi-Torque Flex-T Guide WireDQX · Traditional | 09/11/1986SE |
| K862567 | Acs Wire ShaperDQX · Traditional | 09/04/1986SE |
| K862409 | Snap-On TorquerDQX · Traditional | 07/11/1986SE |
| K861236 | Acs Coronary Guiding CatheterDQO · Traditional | 07/10/1986SE |
| K861847 | Acs Rotating Hemo Valve - Dual Access TypeLOX · Traditional | 06/16/1986SE |
| K861765 | Acs Wholey Hi-Torque Guide WireDQX · Traditional | 05/30/1986SE |
| K861574 | Acs Hi-Torque Tapered Diameter Guide WireDQX · Traditional | 05/28/1986SE |
| K860580 | Acs Brachial Coronary Guiding Cath W/Tapered TipDQO · Traditional | 03/31/1986SE |
| K854830 | Acs Hi-Torque Tapered Diameter Guide WiresDQX · Traditional | 03/31/1986SE |
| K854310 | Acs Indeflator (Modification)DXT · Traditional | 12/04/1985SE |
| K854261 | Advanced Cardiovascular Systems Hemostatic ValvesDTL · Traditional | 12/04/1985SE |
| K853746 | Advanced Cardiovascular Systems Double Lumen BalloLIT · Traditional | 10/21/1985SE |
| K851854 | Advanced Cardiovascular Sys Low Profile Pta BallooLIT · Traditional | 08/05/1985SE |
| K852354 | Wholey Hi-Torque Guide WiresDQX · Traditional | 07/29/1985SE |
| K852123 | Wholey Hi-Torque Guide WiresDQX · Traditional | 06/19/1985SE |
| K851574 | Modifications to Acs Coronary Guiding Catheter W/TDQX · Traditional | 06/19/1985SE |
| K844972 | Adv Cardio Sys DBL Lumen Balloon Dilata CatheterLIT · Traditional | 05/16/1985SE |
| K850353 | Coronary Infusion Catheter W/SideholesDQY · Traditional | 04/10/1985SE |
| K843944 | Ptca Balloon Catheters & AccessoriesLOX · Traditional | 02/14/1985SE |
| K843880 | Low Profile Steerable Balloon DilationLIT · Traditional | 11/27/1984SE |
| K844045 | Advanced Cardiovascular Systems AngiojectDXT · Traditional | 11/13/1984SE |
| K843501 | Balloon Dilation CatheterLIT · Traditional | 10/04/1984SE |
| K842556 | Advanced Cardiovascular Balloon DilataLIT · Traditional | 08/10/1984SE |
| K842195 | Advanced Cardiovascular-Coronary GuidDQO · Traditional | 07/13/1984SE |
| K840795 | Acs Sof-T Guide WireeDQT · Traditional | 07/02/1984SE |
| K841992 | Modification to Acs Coronary GuidingDAO · Traditional | 06/11/1984SE |
| K834433 | Ptca Balloon Catheters & Access. · Traditional | 04/24/1984SE |
| K833801 | Right Coronary Guiding CatheterDQY · Traditional | 03/12/1984SE |
| K833248 | Low Profile Steerable-IntraoperativeLIT · Traditional | 12/22/1983SE |
| K831717 | Coronary Infusion CatheterDQY · Traditional | 06/30/1983SE |
| K831563 | Coronary Guiding Catheter-ModifiedDQY · Traditional | 06/30/1983SE |
| K831403 | Low Profile Steerable Balloon DilataLIT · Traditional | 06/08/1983SE |
| K830829 | Coronary Guiding CatheterDYB · Traditional | 04/28/1983SE |
| K822393 | Intraoperative Balloon Dilation Cath.DQY · Traditional | 11/01/1982SE |
| K822862 | Brachial Coronary Guiding CatheterDQO · Traditional | 10/18/1982SE |
| K822245 | IndeflatorLIT · Traditional | 08/31/1982SE |
| K821190 | Guide WireDQX · Traditional | 08/31/1982SE |
| K821189 | Multipurpose CatheterDQY · Traditional | 07/08/1982SE |
| K821188 | Introducer SetDYB · Traditional | 07/08/1982SE |
PMA approvals
- P810046 Simpson-Robert Coronary Balloon Dilatation Cathete · 03/03/1982 · 221 supplements