Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

103 results for "Advanced Cardiovascular Systems, Inc."
1–24 of 103
Search insights Median review: 81d Cleared: 100% Top manufacturer: Advanced Cardiovascular Systems, Inc. Lead specialty: Cardiovascular
Cleared Jan 24, 2002
HI-TORQUE MIDDLE SUPPORT .012 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING
K012534 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 171d
Cleared Mar 17, 2000
OTW MEGALINK SDS BILIARY STENT SYSTEM
K000550 · FGE
Advanced Cardiovascular Systems, Inc.
Gastroenterology & Urology · 28d
Cleared Feb 25, 2000
VERIPATH PERIPHERAL GUIDING CATHETER
K994229 · DQY
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 71d
Cleared Oct 28, 1999
ACS HI-TORQUE CROSS-IT 400XT GUIDE WIRE
K992169 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 122d
Cleared Sep 02, 1999
RX HERCULINK 14 BILIARY STENT SYSTEM, MODEL...
K990867 · FGE
Advanced Cardiovascular Systems, Inc.
Gastroenterology & Urology · 170d
Cleared Jan 22, 1997
ACS HI-TORQUE IRON MAN GUIDE WIRE
K963702 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 128d
Cleared Sep 12, 1996
INDEFLATOR PLUS 30/PLUS 30 PRIORITY PACK9WITH THE.096 OR.115 ROTATING...
K962495 · MAV
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 78d
Cleared May 08, 1996
INDEFLATOR 20/30 INFLATION DEVICE AND 20/30 PRIORITY PACK (WITH THE .096 OR...
K961471 · MAV
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 21d
Cleared Apr 05, 1996
ACS ANCHOR EXCHANGE DEVICE
K955175 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 144d
Cleared Dec 07, 1995
ACS TOURGIDE GUIDING CATHETER
K953987 · DQY
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 106d
Cleared Aug 04, 1995
ACS POWERBASE GUILDING CATHETER
K952205 · DQY
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 86d
Cleared May 15, 1995
ACS TORQUE DEVICE, ACS GUIDE WIRE INTRODUCER, ACS GUIDE WIRE ACCESSORY KITS
K950752 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 87d
Cleared Apr 05, 1995
ACS HI-TORQUE EXTRA S'PORT(TM) GUIDE WIRE
K950156 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 78d
Cleared Feb 24, 1995
ACS GUIDE WIRES WITH MODIFIED PACKAGE INSERT
K946029 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 77d
Cleared Jul 18, 1994
ACS HI-TORQUE EXTRA S'PORT GUIDE WIRE
K942066 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 80d
Cleared May 03, 1994
ACS POWERBASE(TM) CORONARY GUIDING CATHETER
K940559 · DQY
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 85d
Cleared Apr 13, 1994
ACS ROTATING HEMOSTATIC VALVE & ACS DUOSTAT ROTATING HEMOSTATIC VALVE
K934624 · DYB
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 198d
Cleared Jan 11, 1994
ACS POWERGUIDE CORONARY GUIDING CATHETER
K934009 · DQY
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 146d
Cleared Dec 16, 1993
ACS.018 HI-TORQUE FLOPPY GUIDE WIRE - ACS HI-TORQUE FLOPPY EXTRA SUPPORT...
K934602 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 83d
Cleared Dec 09, 1993
LOC GUIDE WIRE EXTENSION
K934339 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 93d
Cleared Jun 04, 1993
DOC-TITE(TM) GUIDE WIRE EXTENSION
K931171 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 88d
Cleared May 24, 1993
SELECTIVE INFUSION II CATHETER
K914751 · KRA
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 580d
Cleared Mar 23, 1993
ACS ET HI-FLOW/ENHANCED TORQUE CORONARY GUID CATH
K926421 · DQY
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 90d
Cleared Feb 12, 1993
ACS HI-TORQUE BALANCE(TM) GUIDE WIRE
K925381 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 112d