Advanced Cardiovascular Systems, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 103
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K012534 | HI-TORQUE MIDDLE SUPPORT .012 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING | January 24, 2002 |
| K000550 | OTW MEGALINK SDS BILIARY STENT SYSTEM | March 17, 2000 |
| K994229 | VERIPATH PERIPHERAL GUIDING CATHETER | February 25, 2000 |
| K992169 | ACS HI-TORQUE CROSS-IT 400XT GUIDE WIRE | October 28, 1999 |
| K990867 | RX HERCULINK 14 BILIARY STENT SYSTEM, MODEL 1005126-18,1005128-18,1005130-18,1005132-18,1005134-18,1 | September 2, 1999 |
| K963702 | ACS HI-TORQUE IRON MAN GUIDE WIRE | January 22, 1997 |
| K962495 | INDEFLATOR PLUS 30/PLUS 30 PRIORITY PACK9WITH THE.096 OR.115 ROTATING HEMOSTATIC VALVE) | September 12, 1996 |
| K961471 | INDEFLATOR 20/30 INFLATION DEVICE AND 20/30 PRIORITY PACK (WITH THE .096 OR .115 ROTATING HEMOSTATIC | May 8, 1996 |
| K955175 | ACS ANCHOR EXCHANGE DEVICE | April 5, 1996 |
| K953987 | ACS TOURGIDE GUIDING CATHETER | December 7, 1995 |
| K952205 | ACS POWERBASE GUILDING CATHETER | August 4, 1995 |
| K950752 | ACS TORQUE DEVICE, ACS GUIDE WIRE INTRODUCER, ACS GUIDE WIRE ACCESSORY KITS | May 15, 1995 |
| K950156 | ACS HI-TORQUE EXTRA S'PORT(TM) GUIDE WIRE | April 5, 1995 |
| K946029 | ACS GUIDE WIRES WITH MODIFIED PACKAGE INSERT | February 24, 1995 |
| K942066 | ACS HI-TORQUE EXTRA S'PORT GUIDE WIRE | July 18, 1994 |
| K940559 | ACS POWERBASE(TM) CORONARY GUIDING CATHETER | May 3, 1994 |
| K934624 | ACS ROTATING HEMOSTATIC VALVE & ACS DUOSTAT ROTATING HEMOSTATIC VALVE | April 13, 1994 |
| K934009 | ACS POWERGUIDE CORONARY GUIDING CATHETER | January 11, 1994 |
| K934602 | ACS.018 HI-TORQUE FLOPPY GUIDE WIRE - ACS HI-TORQUE FLOPPY EXTRA SUPPORT GUIDE WIRE | December 16, 1993 |
| K934339 | LOC GUIDE WIRE EXTENSION | December 9, 1993 |