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."
25–48 of 103
Search insights Median review: 81d Cleared: 100% Top manufacturer: Advanced Cardiovascular Systems, Inc. Lead specialty: Cardiovascular
Cleared Aug 07, 1992
ACS ANGIOTRAK(TM) SYSTEM
K921719 · MAV
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 120d
Cleared Jun 09, 1992
.10' HI-TORQUE FLOPPY, INTER. & STAND. GUIDE WIRE
K915723 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 172d
Cleared Jan 08, 1992
010 HI-TOR INTER/STAND GUIDWIRE PRESHAPE TIP/MODIF
K914828 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 76d
Cleared Oct 28, 1991
.014 HI-TORQUE FLOPPY PATHFINDER GUIDE WIRE
K913631 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 74d
Cleared Oct 23, 1991
VASCULAR GUIDE WIRE
K913353 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 89d
Cleared Oct 23, 1991
.010 HI-TORQUE PLUS(TM) GUIDE WIRE
K913328 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 90d
Cleared Oct 08, 1991
ACS VSW GUIDE WIRE
K913178 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 83d
Cleared Sep 06, 1991
ACS RX SUPPORT CATHETER
K911957 · DQO
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 127d
Cleared Jun 25, 1991
.010 HI-TORQUE GUIDE WIRES WITH PRESHAPED TIP
K911460 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 83d
Cleared Mar 18, 1991
ACS ANGIOSCOPIC CATHETER
K905715 · DQO
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 87d
Cleared Feb 04, 1991
.010 HI-TORQUE FLOPPY GUIDE WIRE W/PRESHAPED TIP
K905502 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 59d
Cleared Jan 03, 1991
ACS URETHAN CORONARY GUIDING CATHETER
K904884 · DQY
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 69d
Cleared Sep 04, 1990
.018 HI-TORQUE FLOPPY GUIDE WIRE W/ PRESHAPED TIP
K902755 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 74d
Cleared Aug 08, 1990
ACS .010 HI-TORQUE INTER. AND STANDARD GUIDE WIRE
K902207 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 84d
Cleared Jun 12, 1990
ACS ADVANCED CONCEPT GUIDE WIRE
K900386 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 134d
Cleared Feb 28, 1990
ACS INDEFLATOR XX
K896849 · MAV
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 85d
Cleared Feb 02, 1990
ACS GOLD SERIES ELASTINITE GUIDE WIRE
K896379 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 88d
Cleared Mar 31, 1989
ACS 0.015 & 0.018 PRESSURE GUIDE WIRE W/MICRO.
K882507 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 287d
Cleared Mar 16, 1989
ACS SELECTIVE INFUSION CATHETER
K885237 · DQY
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 85d
Cleared Feb 06, 1989
ACS 0.010 HI-TORQUE FLOPPY GOLD GUIDE WIRE
K884895 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 76d
Cleared Dec 21, 1988
ACS(R) HI-TORQUE GOLD(TM) GUIDE WIRE
K884262 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 71d
Cleared Nov 03, 1988
ACS SOFT-TIP CORONARY INFUSION CATH W/SIDE HOLES
K883564 · DQY
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 73d
Cleared Oct 14, 1988
ACS INDEFLATOR P/T 20
K883452 · DXT
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 63d
Cleared Sep 28, 1988
ACS ANGIOSCOPE GUIDE WIRE
K883000 · LYK
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 72d