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."
49–72 of 103
Search insights Median review: 81d Cleared: 100% Top manufacturer: Advanced Cardiovascular Systems, Inc. Lead specialty: Cardiovascular
Cleared Sep 28, 1988
ACS SCHWARTEN XT BALLOON DILATATION CATHETER
K882925 · LIT
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 77d
Cleared Sep 27, 1988
TAD INTERMEDIATE & TAD STANDARD GUIDE WIRE
K882928 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 81d
Cleared Sep 27, 1988
ACS CORONARY ANGIOSCOPIC CATHETER
K875108 · LYK
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 288d
Cleared Sep 16, 1988
ET HI-FLOW SOFT TIP/ET HI-FLOW/ENHANCED TORQUE ST
K882803 · DQY
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 71d
Cleared Aug 30, 1988
ACS DEFLECTABLE TIP GUIDE WIRE W/MICROGLIDE(R)COAT
K882321 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 85d
Cleared Aug 03, 1988
ACS HI-TORQUE FLOPPY/FLOPPY II/INTER./STANDARD GW
K881897 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 89d
Cleared Jul 25, 1988
ACS HI-TORQUE STANDARD & INTERMEDI. GUIDE WIRE
K881787 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 90d
Cleared May 31, 1988
ACS FUNNEL INTRODUCER
K875158 · DYB
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 168d
Cleared Apr 28, 1988
ACS HI-TORQUE GUIDE WIRES
K874202 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 196d
Cleared Feb 18, 1988
ACS HI-TORQUE CORONARY GUIDING CATHETER W/SOFT TIP
K874874 · DQY
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 83d
Cleared Feb 17, 1988
ACS 0.025-IN HI-TORQ MODIF J/STAND TELESC GUIDEWIR
K874776 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 90d
Cleared Feb 12, 1988
ACS SOFT-TIP CORONARY INFUSION CATHETER W/SIDEHOLE
K875269 · DQY
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 52d
Cleared Oct 20, 1987
ACS INDEFLATOR PLUS (MODIFICATION #2)
K872981 · DXT
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 81d
Cleared Aug 21, 1987
ACS HI-TORQUE FLEX-T GUIDE WIRE (MODIFICATION)
K872220 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 73d
Cleared May 22, 1987
ACS ENHANCED-TORQUE CORONARY GUIDING CATHETER
K871425 · DQY
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 44d
Cleared Dec 05, 1986
ACS HI-TORQUE FLOPPY GUIDE WIRE, 0.018 INCH
K864585 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 18d
Cleared Sep 11, 1986
ACS HI-TORQUE FLEX-T GUIDE WIRE
K862360 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 80d
Cleared Sep 04, 1986
ACS WIRE SHAPER
K862567 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 59d
Cleared Jul 11, 1986
SNAP-ON TORQUER
K862409 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 16d
Cleared Jul 10, 1986
ACS CORONARY GUIDING CATHETER
K861236 · DQO
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 99d
Cleared Jun 16, 1986
ACS ROTATING HEMO VALVE - DUAL ACCESS TYPE
K861847 · LOX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 34d
Cleared May 30, 1986
ACS WHOLEY HI-TORQUE GUIDE WIRE
K861765 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 23d
Cleared May 28, 1986
ACS HI-TORQUE TAPERED DIAMETER GUIDE WIRE
K861574 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 30d
Cleared Mar 31, 1986
ACS BRACHIAL CORONARY GUIDING CATH W/TAPERED TIP
K860580 · DQO
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 41d