Company ยท US
Advanced Cardiovascular Systems, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1982 to 2002. Name variants (Inc, Corp, punctuation) are merged.
103510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DQX | Wire, Guide, Catheter | 45 |
| DQY | Catheter, Percutaneous | 19 |
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | 10 |
| DQO | Catheter, Intravascular, Diagnostic | 6 |
| DXT | Injector And Syringe, Angiographic | 4 |
| DYB | Introducer, Catheter | 4 |
| MAV | Syringe, Balloon Inflation | 4 |
| FGE | Stents, Drains And Dilators For The Biliary Ducts | 2 |
| LOX | Catheters, Transluminal Coronary Angioplasty, Percutaneous | 2 |
| LYK | Angioscope | 2 |
| DAO | Igm (Mu Chain Specific), Antigen, Antiserum, Control | 1 |
| DQT | Occluder, Catheter Tip | 1 |
| DTL | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | 1 |
| KRA | Catheter, Continuous Flush | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 24, 2002 | K012534 | HI-TORQUE MIDDLE SUPPORT .012 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING Advanced Cardiovascular Systems, Inc. | DQX |
| Mar 17, 2000 | K000550 | OTW MEGALINK SDS BILIARY STENT SYSTEM Advanced Cardiovascular Systems, Inc. | FGE |
| Feb 25, 2000 | K994229 | VERIPATH PERIPHERAL GUIDING CATHETER Advanced Cardiovascular Systems, Inc. | DQY |
| Oct 28, 1999 | K992169 | ACS HI-TORQUE CROSS-IT 400XT GUIDE WIRE Advanced Cardiovascular Systems, Inc. | DQX |
| Sep 2, 1999 | K990867 | RX HERCULINK 14 BILIARY STENT SYSTEM, MODEL 1005126-18,1005128-18,1005130-18,1005132-18,1005134-18,1005136-18,1005138-18 Advanced Cardiovascular Systems, Inc. | FGE |
| Jan 22, 1997 | K963702 | ACS HI-TORQUE IRON MAN GUIDE WIRE Advanced Cardiovascular Systems, Inc. | DQX |
| Sep 12, 1996 | K962495 | INDEFLATOR PLUS 30/PLUS 30 PRIORITY PACK9WITH THE.096 OR.115 ROTATING HEMOSTATIC VALVE) Advanced Cardiovascular Systems, Inc. | MAV |
| May 8, 1996 | K961471 | INDEFLATOR 20/30 INFLATION DEVICE AND 20/30 PRIORITY PACK (WITH THE .096 OR .115 ROTATING HEMOSTATIC VALVE) Advanced Cardiovascular Systems, Inc. | MAV |
| Apr 5, 1996 | K955175 | ACS ANCHOR EXCHANGE DEVICE Advanced Cardiovascular Systems, Inc. | DQX |
| Dec 7, 1995 | K953987 | ACS TOURGIDE GUIDING CATHETER Advanced Cardiovascular Systems, Inc. | DQY |
| Aug 4, 1995 | K952205 | ACS POWERBASE GUILDING CATHETER Advanced Cardiovascular Systems, Inc. | DQY |
| May 15, 1995 | K950752 | ACS TORQUE DEVICE, ACS GUIDE WIRE INTRODUCER, ACS GUIDE WIRE ACCESSORY KITS Advanced Cardiovascular Systems, Inc. | DQX |
| Apr 5, 1995 | K950156 | ACS HI-TORQUE EXTRA S'PORT(TM) GUIDE WIRE Advanced Cardiovascular Systems, Inc. | DQX |
| Feb 24, 1995 | K946029 | ACS GUIDE WIRES WITH MODIFIED PACKAGE INSERT Advanced Cardiovascular Systems, Inc. | DQX |
| Jul 18, 1994 | K942066 | ACS HI-TORQUE EXTRA S'PORT GUIDE WIRE Advanced Cardiovascular Systems, Inc. | DQX |
| May 3, 1994 | K940559 | ACS POWERBASE(TM) CORONARY GUIDING CATHETER Advanced Cardiovascular Systems, Inc. | DQY |
| Apr 13, 1994 | K934624 | ACS ROTATING HEMOSTATIC VALVE & ACS DUOSTAT ROTATING HEMOSTATIC VALVE Advanced Cardiovascular Systems, Inc. | DYB |
| Jan 11, 1994 | K934009 | ACS POWERGUIDE CORONARY GUIDING CATHETER Advanced Cardiovascular Systems, Inc. | DQY |
| Dec 16, 1993 | K934602 | ACS.018 HI-TORQUE FLOPPY GUIDE WIRE - ACS HI-TORQUE FLOPPY EXTRA SUPPORT GUIDE WIRE Advanced Cardiovascular Systems, Inc. | DQX |
| Dec 9, 1993 | K934339 | LOC GUIDE WIRE EXTENSION Advanced Cardiovascular Systems, Inc. | DQX |
| Jun 4, 1993 | K931171 | DOC-TITE(TM) GUIDE WIRE EXTENSION Advanced Cardiovascular Systems, Inc. | DQX |
| May 24, 1993 | K914751 | SELECTIVE INFUSION II CATHETER Advanced Cardiovascular Systems, Inc. | KRA |
| Mar 23, 1993 | K926421 | ACS ET HI-FLOW/ENHANCED TORQUE CORONARY GUID CATH Advanced Cardiovascular Systems, Inc. | DQY |
| Feb 12, 1993 | K925381 | ACS HI-TORQUE BALANCE(TM) GUIDE WIRE Advanced Cardiovascular Systems, Inc. | DQX |
| Aug 7, 1992 | K921719 | ACS ANGIOTRAK(TM) SYSTEM Advanced Cardiovascular Systems, Inc. | MAV |
| Jun 9, 1992 | K915723 | .10' HI-TORQUE FLOPPY, INTER. & STAND. GUIDE WIRE Advanced Cardiovascular Systems, Inc. | DQX |
| Jan 8, 1992 | K914828 | 010 HI-TOR INTER/STAND GUIDWIRE PRESHAPE TIP/MODIF Advanced Cardiovascular Systems, Inc. | DQX |
| Oct 28, 1991 | K913631 | .014 HI-TORQUE FLOPPY PATHFINDER GUIDE WIRE Advanced Cardiovascular Systems, Inc. | DQX |
| Oct 23, 1991 | K913353 | VASCULAR GUIDE WIRE Advanced Cardiovascular Systems, Inc. | DQX |
| Oct 23, 1991 | K913328 | .010 HI-TORQUE PLUS(TM) GUIDE WIRE Advanced Cardiovascular Systems, Inc. | DQX |
| Oct 8, 1991 | K913178 | ACS VSW GUIDE WIRE Advanced Cardiovascular Systems, Inc. | DQX |
| Sep 6, 1991 | K911957 | ACS RX SUPPORT CATHETER Advanced Cardiovascular Systems, Inc. | DQO |
| Jun 25, 1991 | K911460 | .010 HI-TORQUE GUIDE WIRES WITH PRESHAPED TIP Advanced Cardiovascular Systems, Inc. | DQX |
| Mar 18, 1991 | K905715 | ACS ANGIOSCOPIC CATHETER Advanced Cardiovascular Systems, Inc. | DQO |
| Feb 4, 1991 | K905502 | .010 HI-TORQUE FLOPPY GUIDE WIRE W/PRESHAPED TIP Advanced Cardiovascular Systems, Inc. | DQX |
| Jan 3, 1991 | K904884 | ACS URETHAN CORONARY GUIDING CATHETER Advanced Cardiovascular Systems, Inc. | DQY |
| Sep 4, 1990 | K902755 | .018 HI-TORQUE FLOPPY GUIDE WIRE W/ PRESHAPED TIP Advanced Cardiovascular Systems, Inc. | DQX |
| Aug 8, 1990 | K902207 | ACS .010 HI-TORQUE INTER. AND STANDARD GUIDE WIRE Advanced Cardiovascular Systems, Inc. | DQX |
| Jun 12, 1990 | K900386 | ACS ADVANCED CONCEPT GUIDE WIRE Advanced Cardiovascular Systems, Inc. | DQX |
| Feb 28, 1990 | K896849 | ACS INDEFLATOR XX Advanced Cardiovascular Systems, Inc. | MAV |
| Feb 2, 1990 | K896379 | ACS GOLD SERIES ELASTINITE GUIDE WIRE Advanced Cardiovascular Systems, Inc. | DQX |
| Mar 31, 1989 | K882507 | ACS 0.015 & 0.018 PRESSURE GUIDE WIRE W/MICRO. Advanced Cardiovascular Systems, Inc. | DQX |
| Mar 16, 1989 | K885237 | ACS SELECTIVE INFUSION CATHETER Advanced Cardiovascular Systems, Inc. | DQY |
| Feb 6, 1989 | K884895 | ACS 0.010 HI-TORQUE FLOPPY GOLD GUIDE WIRE Advanced Cardiovascular Systems, Inc. | DQX |
| Dec 21, 1988 | K884262 | ACS(R) HI-TORQUE GOLD(TM) GUIDE WIRE Advanced Cardiovascular Systems, Inc. | DQX |
| Nov 3, 1988 | K883564 | ACS SOFT-TIP CORONARY INFUSION CATH W/SIDE HOLES Advanced Cardiovascular Systems, Inc. | DQY |
| Oct 14, 1988 | K883452 | ACS INDEFLATOR P/T 20 Advanced Cardiovascular Systems, Inc. | DXT |
| Sep 28, 1988 | K883000 | ACS ANGIOSCOPE GUIDE WIRE Advanced Cardiovascular Systems, Inc. | LYK |
| Sep 28, 1988 | K882925 | ACS SCHWARTEN XT BALLOON DILATATION CATHETER Advanced Cardiovascular Systems, Inc. | LIT |
| Sep 27, 1988 | K882928 | TAD INTERMEDIATE & TAD STANDARD GUIDE WIRE Advanced Cardiovascular Systems, Inc. | DQX |
Newest 50 of 103.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||