Medical Device Manufacturer · US , Santa Clara , CA

Advanced Cardiovascular Systems, Inc. - FDA 510(k) Cleared Devices

103 submissions · 100 cleared · Since 1982
103
Total
100
Cleared
0
Denied
99 devices
76-99 of 99
Cleared Jul 29, 1985
WHOLEY HI-TORQUE GUIDE WIRES
K852354 · DQX
Cardiovascular · 56d
Cleared Jun 19, 1985
MODIFICATIONS TO ACS CORONARY GUIDING CATHETER W/T
K851574 · DQX
Cardiovascular · 63d
Cleared Jun 19, 1985
WHOLEY HI-TORQUE GUIDE WIRES
K852123 · DQX
Cardiovascular · 35d
Cleared May 16, 1985
ADV CARDIO SYS DBL LUMEN BALLOON DILATA CATHETER
K844972 · LIT
Cardiovascular · 143d
Cleared Apr 10, 1985
CORONARY INFUSION CATHETER W/SIDEHOLES
K850353 · DQY
Cardiovascular · 71d
Cleared Feb 14, 1985
PTCA BALLOON CATHETERS & ACCESSORIES
K843944 · LOX
Cardiovascular · 128d
Cleared Nov 27, 1984
LOW PROFILE STEERABLE BALLOON DILATION
K843880 · LIT
Cardiovascular · 56d
Cleared Nov 13, 1984
ADVANCED CARDIOVASCULAR SYSTEMS ANGIOJECT
K844045 · DXT
Cardiovascular · 27d
Cleared Oct 04, 1984
BALLOON DILATION CATHETER
K843501 · LIT
Cardiovascular · 28d
Cleared Aug 10, 1984
ADVANCED CARDIOVASCULAR BALLOON DILATA
K842556 · LIT
Cardiovascular · 39d
Cleared Jul 13, 1984
ADVANCED CARDIOVASCULAR-CORONARY GUID
K842195 · DQO
Cardiovascular · 39d
Cleared Jul 02, 1984
ACS SOF-T GUIDE WIREE
K840795 · DQT
Cardiovascular · 130d
Cleared Mar 12, 1984
RIGHT CORONARY GUIDING CATHETER
K833801 · DQY
Cardiovascular · 132d
Cleared Dec 22, 1983
LOW PROFILE STEERABLE-INTRAOPERATIVE
K833248 · LIT
Cardiovascular · 98d
Cleared Jun 30, 1983
CORONARY GUIDING CATHETER-MODIFIED
K831563 · DQY
Cardiovascular · 45d
Cleared Jun 30, 1983
CORONARY INFUSION CATHETER
K831717 · DQY
Cardiovascular · 30d
Cleared Jun 08, 1983
LOW PROFILE STEERABLE BALLOON DILATA
K831403 · LIT
Cardiovascular · 37d
Cleared Apr 28, 1983
CORONARY GUIDING CATHETER
K830829 · DYB
Cardiovascular · 45d
Cleared Nov 01, 1982
INTRAOPERATIVE BALLOON DILATION CATH.
K822393 · DQY
Cardiovascular · 84d
Cleared Oct 18, 1982
BRACHIAL CORONARY GUIDING CATHETER
K822862 · DQO
Cardiovascular · 21d
Cleared Aug 31, 1982
GUIDE WIRE
K821190 · DQX
Cardiovascular · 126d
Cleared Aug 31, 1982
INDEFLATOR
K822245 · LIT
Cardiovascular · 33d
Cleared Jul 08, 1982
INTRODUCER SET
K821188 · DYB
Cardiovascular · 72d
Cleared Jul 08, 1982
MULTIPURPOSE CATHETER
K821189 · DQY
Cardiovascular · 72d

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