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."
73–96 of 103
Search insights Median review: 81d Cleared: 100% Top manufacturer: Advanced Cardiovascular Systems, Inc. Lead specialty: Cardiovascular
Cleared Mar 31, 1986
ACS HI-TORQUE TAPERED DIAMETER GUIDE WIRES
K854830 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 118d
Cleared Dec 04, 1985
ACS INDEFLATOR (MODIFICATION)
K854310 · DXT
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 41d
Cleared Dec 04, 1985
ADVANCED CARDIOVASCULAR SYSTEMS HEMOSTATIC VALVES
K854261 · DTL
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 42d
Cleared Oct 21, 1985
ADVANCED CARDIOVASCULAR SYSTEMS DOUBLE LUMEN BALLO
K853746 · LIT
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 42d
Cleared Aug 05, 1985
ADVANCED CARDIOVASCULAR SYS LOW PROFILE PTA BALLOO
K851854 · LIT
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 101d
Cleared Jul 29, 1985
WHOLEY HI-TORQUE GUIDE WIRES
K852354 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 56d
Cleared Jun 19, 1985
WHOLEY HI-TORQUE GUIDE WIRES
K852123 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 35d
Cleared Jun 19, 1985
MODIFICATIONS TO ACS CORONARY GUIDING CATHETER W/T
K851574 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 63d
Cleared May 16, 1985
ADV CARDIO SYS DBL LUMEN BALLOON DILATA CATHETER
K844972 · LIT
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 143d
Cleared Apr 10, 1985
CORONARY INFUSION CATHETER W/SIDEHOLES
K850353 · DQY
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 71d
Cleared Feb 14, 1985
PTCA BALLOON CATHETERS & ACCESSORIES
K843944 · LOX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 128d
Cleared Nov 27, 1984
LOW PROFILE STEERABLE BALLOON DILATION
K843880 · LIT
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 56d
Cleared Nov 13, 1984
ADVANCED CARDIOVASCULAR SYSTEMS ANGIOJECT
K844045 · DXT
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 27d
Cleared Oct 04, 1984
BALLOON DILATION CATHETER
K843501 · LIT
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 28d
Cleared Aug 10, 1984
ADVANCED CARDIOVASCULAR BALLOON DILATA
K842556 · LIT
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 39d
Cleared Jul 13, 1984
ADVANCED CARDIOVASCULAR-CORONARY GUID
K842195 · DQO
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 39d
Cleared Jul 02, 1984
ACS SOF-T GUIDE WIREE
K840795 · DQT
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 130d
Cleared Jun 11, 1984
MODIFICATION TO ACS CORONARY GUIDING
K841992 · DAO
Advanced Cardiovascular Systems, Inc.
Immunology · 47d
Cleared Apr 24, 1984
PTCA BALLOON CATHETERS & ACCESS.
K834433
Advanced Cardiovascular Systems, Inc.
General & Plastic Surgery · 139d
Cleared Mar 12, 1984
RIGHT CORONARY GUIDING CATHETER
K833801 · DQY
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 132d
Cleared Dec 22, 1983
LOW PROFILE STEERABLE-INTRAOPERATIVE
K833248 · LIT
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 98d
Cleared Jun 30, 1983
CORONARY INFUSION CATHETER
K831717 · DQY
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 30d
Cleared Jun 30, 1983
CORONARY GUIDING CATHETER-MODIFIED
K831563 · DQY
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 45d
Cleared Jun 08, 1983
LOW PROFILE STEERABLE BALLOON DILATA
K831403 · LIT
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 37d