Advanced Cardiovascular Systems, Inc.
Santa Clara, CA, US
Advanced Cardiovascular Systems, Inc. appears in FDA device records in Santa Clara, CA. FDA records list 103 510(k) clearances between and , 222 PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 103
- PMA records
- 222
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
Showing 50 of 103FDA records hold 103 510(k) clearances for Advanced Cardiovascular Systems, Inc. between 1982 and 2002. The busiest year on record is 1988, with 16. The most recent is 2002, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1982 | 6 |
| 1983 | 5 |
| 1984 | 9 |
| 1985 | 10 |
| 1986 | 10 |
| 1987 | 3 |
| 1988 | 16 |
| 1989 | 3 |
| 1990 | 5 |
| 1991 | 9 |
| 1992 | 3 |
| 1993 | 6 |
| 1994 | 4 |
| 1995 | 5 |
| 1996 | 3 |
| 1997 | 1 |
| 1999 | 2 |
| 2000 | 2 |
| 2002 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K012534 | HI-TORQUE MIDDLE SUPPORT .012 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING | DQX | Substantially Equivalent | |
| K000550 | OTW MEGALINK SDS BILIARY STENT SYSTEM | FGE | Unknown | |
| K994229 | VERIPATH PERIPHERAL GUIDING CATHETER | DQY | Substantially Equivalent | |
| K992169 | ACS HI-TORQUE CROSS-IT 400XT GUIDE WIRE | DQX | Substantially Equivalent | |
| K990867 | RX HERCULINK 14 BILIARY STENT SYSTEM, MODEL 1005126-18,1005128-18,1005130-18,1005132-18,1005134-18,1005136-18,1005138-18 | FGE | Unknown | |
| K963702 | ACS HI-TORQUE IRON MAN GUIDE WIRE | DQX | Substantially Equivalent | |
| K962495 | INDEFLATOR PLUS 30/PLUS 30 PRIORITY PACK9WITH THE.096 OR.115 ROTATING HEMOSTATIC VALVE) | MAV | Substantially Equivalent | |
| K961471 | INDEFLATOR 20/30 INFLATION DEVICE AND 20/30 PRIORITY PACK (WITH THE .096 OR .115 ROTATING HEMOSTATIC VALVE) | MAV | Unknown | |
| K955175 | ACS ANCHOR EXCHANGE DEVICE | DQX | Substantially Equivalent | |
| K953987 | ACS TOURGIDE GUIDING CATHETER | DQY | Substantially Equivalent | |
| K952205 | ACS POWERBASE GUILDING CATHETER | DQY | Substantially Equivalent | |
| K950752 | ACS TORQUE DEVICE, ACS GUIDE WIRE INTRODUCER, ACS GUIDE WIRE ACCESSORY KITS | DQX | Substantially Equivalent | |
| K950156 | ACS HI-TORQUE EXTRA S'PORT(TM) GUIDE WIRE | DQX | Substantially Equivalent | |
| K946029 | ACS GUIDE WIRES WITH MODIFIED PACKAGE INSERT | DQX | Substantially Equivalent | |
| K942066 | ACS HI-TORQUE EXTRA S'PORT GUIDE WIRE | DQX | Substantially Equivalent | |
| K940559 | ACS POWERBASE(TM) CORONARY GUIDING CATHETER | DQY | Substantially Equivalent | |
| K934624 | ACS ROTATING HEMOSTATIC VALVE & ACS DUOSTAT ROTATING HEMOSTATIC VALVE | DYB | Substantially Equivalent | |
| K934009 | ACS POWERGUIDE CORONARY GUIDING CATHETER | DQY | Substantially Equivalent | |
| K934602 | ACS.018 HI-TORQUE FLOPPY GUIDE WIRE - ACS HI-TORQUE FLOPPY EXTRA SUPPORT GUIDE WIRE | DQX | Substantially Equivalent | |
| K934339 | LOC GUIDE WIRE EXTENSION | DQX | Substantially Equivalent | |
| K931171 | DOC-TITE(TM) GUIDE WIRE EXTENSION | DQX | Substantially Equivalent | |
| K914751 | SELECTIVE INFUSION II CATHETER | KRA | Substantially Equivalent | |
| K926421 | ACS ET HI-FLOW/ENHANCED TORQUE CORONARY GUID CATH | DQY | Substantially Equivalent | |
| K925381 | ACS HI-TORQUE BALANCE(TM) GUIDE WIRE | DQX | Substantially Equivalent | |
| K921719 | ACS ANGIOTRAK(TM) SYSTEM | MAV | Substantially Equivalent | |
| K915723 | .10' HI-TORQUE FLOPPY, INTER. & STAND. GUIDE WIRE | DQX | Substantially Equivalent | |
| K914828 | 010 HI-TOR INTER/STAND GUIDWIRE PRESHAPE TIP/MODIF | DQX | Substantially Equivalent | |
| K913631 | .014 HI-TORQUE FLOPPY PATHFINDER GUIDE WIRE | DQX | Substantially Equivalent | |
| K913353 | VASCULAR GUIDE WIRE | DQX | Substantially Equivalent | |
| K913328 | .010 HI-TORQUE PLUS(TM) GUIDE WIRE | DQX | Substantially Equivalent | |
| K913178 | ACS VSW GUIDE WIRE | DQX | Substantially Equivalent | |
| K911957 | ACS RX SUPPORT CATHETER | DQO | Substantially Equivalent | |
| K911460 | .010 HI-TORQUE GUIDE WIRES WITH PRESHAPED TIP | DQX | Substantially Equivalent | |
| K905715 | ACS ANGIOSCOPIC CATHETER | DQO | Substantially Equivalent | |
| K905502 | .010 HI-TORQUE FLOPPY GUIDE WIRE W/PRESHAPED TIP | DQX | Substantially Equivalent | |
| K904884 | ACS URETHAN CORONARY GUIDING CATHETER | DQY | Substantially Equivalent | |
| K902755 | .018 HI-TORQUE FLOPPY GUIDE WIRE W/ PRESHAPED TIP | DQX | Substantially Equivalent | |
| K902207 | ACS .010 HI-TORQUE INTER. AND STANDARD GUIDE WIRE | DQX | Substantially Equivalent | |
| K900386 | ACS ADVANCED CONCEPT GUIDE WIRE | DQX | Substantially Equivalent | |
| K896849 | ACS INDEFLATOR XX | MAV | Substantially Equivalent | |
| K896379 | ACS GOLD SERIES ELASTINITE GUIDE WIRE | DQX | Substantially Equivalent | |
| K882507 | ACS 0.015 & 0.018 PRESSURE GUIDE WIRE W/MICRO. | DQX | Substantially Equivalent | |
| K885237 | ACS SELECTIVE INFUSION CATHETER | DQY | Substantially Equivalent | |
| K884895 | ACS 0.010 HI-TORQUE FLOPPY GOLD GUIDE WIRE | DQX | Substantially Equivalent | |
| K884262 | ACS(R) HI-TORQUE GOLD(TM) GUIDE WIRE | DQX | Substantially Equivalent | |
| K883564 | ACS SOFT-TIP CORONARY INFUSION CATH W/SIDE HOLES | DQY | Substantially Equivalent | |
| K883452 | ACS INDEFLATOR P/T 20 | DXT | Substantially Equivalent | |
| K883000 | ACS ANGIOSCOPE GUIDE WIRE | LYK | Substantially Equivalent | |
| K882925 | ACS SCHWARTEN XT BALLOON DILATATION CATHETER | LIT | Substantially Equivalent | |
| K882928 | TAD INTERMEDIATE & TAD STANDARD GUIDE WIRE | DQX | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- DTLAdaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
- LYKAngioscope
- LITCatheter, Angioplasty, Peripheral, Transluminal
- KRACatheter, Continuous Flush
- DYGCatheter, Flow Directed
- DQOCatheter, Intravascular, Diagnostic
- DQYCatheter, Percutaneous
- LOXCatheters, Transluminal Coronary Angioplasty, Percutaneous
- DAOIgm (Mu Chain Specific), Antigen, Antiserum, Control
- DXTInjector And Syringe, Angiographic
- DYBIntroducer, Catheter
- DQTOccluder, Catheter Tip
- MAFStent, Coronary
- FGEStents, Drains And Dilators For The Biliary Ducts
- MAVSyringe, Balloon Inflation
- DQXWire, Guide, Catheter
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain