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
51-75 of 99
Cleared Aug 30, 1988
ACS DEFLECTABLE TIP GUIDE WIRE W/MICROGLIDE(R)COAT
K882321 · DQX
Cardiovascular · 85d
Cleared Aug 03, 1988
ACS HI-TORQUE FLOPPY/FLOPPY II/INTER./STANDARD GW
K881897 · DQX
Cardiovascular · 89d
Cleared Jul 25, 1988
ACS HI-TORQUE STANDARD & INTERMEDI. GUIDE WIRE
K881787 · DQX
Cardiovascular · 90d
Cleared May 31, 1988
ACS FUNNEL INTRODUCER
K875158 · DYB
Cardiovascular · 168d
Cleared Apr 28, 1988
ACS HI-TORQUE GUIDE WIRES
K874202 · DQX
Cardiovascular · 196d
Cleared Feb 18, 1988
ACS HI-TORQUE CORONARY GUIDING CATHETER W/SOFT TIP
K874874 · DQY
Cardiovascular · 83d
Cleared Feb 17, 1988
ACS 0.025-IN HI-TORQ MODIF J/STAND TELESC GUIDEWIR
K874776 · DQX
Cardiovascular · 90d
Cleared Feb 12, 1988
ACS SOFT-TIP CORONARY INFUSION CATHETER W/SIDEHOLE
K875269 · DQY
Cardiovascular · 52d
Cleared Oct 20, 1987
ACS INDEFLATOR PLUS (MODIFICATION #2)
K872981 · DXT
Cardiovascular · 81d
Cleared Aug 21, 1987
ACS HI-TORQUE FLEX-T GUIDE WIRE (MODIFICATION)
K872220 · DQX
Cardiovascular · 73d
Cleared May 22, 1987
ACS ENHANCED-TORQUE CORONARY GUIDING CATHETER
K871425 · DQY
Cardiovascular · 44d
Cleared Dec 05, 1986
ACS HI-TORQUE FLOPPY GUIDE WIRE, 0.018 INCH
K864585 · DQX
Cardiovascular · 18d
Cleared Sep 11, 1986
ACS HI-TORQUE FLEX-T GUIDE WIRE
K862360 · DQX
Cardiovascular · 80d
Cleared Sep 04, 1986
ACS WIRE SHAPER
K862567 · DQX
Cardiovascular · 59d
Cleared Jul 11, 1986
SNAP-ON TORQUER
K862409 · DQX
Cardiovascular · 16d
Cleared Jul 10, 1986
ACS CORONARY GUIDING CATHETER
K861236 · DQO
Cardiovascular · 99d
Cleared Jun 16, 1986
ACS ROTATING HEMO VALVE - DUAL ACCESS TYPE
K861847 · LOX
Cardiovascular · 34d
Cleared May 30, 1986
ACS WHOLEY HI-TORQUE GUIDE WIRE
K861765 · DQX
Cardiovascular · 23d
Cleared May 28, 1986
ACS HI-TORQUE TAPERED DIAMETER GUIDE WIRE
K861574 · DQX
Cardiovascular · 30d
Cleared Mar 31, 1986
ACS HI-TORQUE TAPERED DIAMETER GUIDE WIRES
K854830 · DQX
Cardiovascular · 118d
Cleared Mar 31, 1986
ACS BRACHIAL CORONARY GUIDING CATH W/TAPERED TIP
K860580 · DQO
Cardiovascular · 41d
Cleared Dec 04, 1985
ADVANCED CARDIOVASCULAR SYSTEMS HEMOSTATIC VALVES
K854261 · DTL
Cardiovascular · 42d
Cleared Dec 04, 1985
ACS INDEFLATOR (MODIFICATION)
K854310 · DXT
Cardiovascular · 41d
Cleared Oct 21, 1985
ADVANCED CARDIOVASCULAR SYSTEMS DOUBLE LUMEN BALLO
K853746 · LIT
Cardiovascular · 42d
Cleared Aug 05, 1985
ADVANCED CARDIOVASCULAR SYS LOW PROFILE PTA BALLOO
K851854 · LIT
Cardiovascular · 101d

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