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

71 results for "Guidant Corp."
1–24 of 71
Search insights Median review: 33d Cleared: 100% Top manufacturer: Guidant Corp. Lead specialty: Cardiovascular
Cleared Jul 27, 2006
FLEX 10 MIS ABLATION PROBE, MODEL FLX10MI-05
K061865 · NEY
Guidant Corp.
General & Plastic Surgery · 24d
Cleared Jun 22, 2006
HI-TORQUE WHISPER VIEW GUIDE WIRE
K061453 · DQX
Guidant Corp.
Cardiovascular · 28d
Cleared Nov 12, 2004
RX ACCUNET 2 EMBOLIC PROTECTION SYSTEM
K042908 · NTE
Guidant Corp.
Cardiovascular · 22d
Cleared Aug 31, 2004
ACCUNET EMBOLIC PROTECTION SYSTEM, RX ACCUNET EMBOLIC PROTECTION SYSTEM
K042218 · NTE
Guidant Corp.
Cardiovascular · 26d
Cleared Jan 02, 2004
OMNILINK .018 BILIARY STENT SYSTEM
K033834 · FGE
Guidant Corp.
Gastroenterology & Urology · 23d
Cleared Nov 10, 2003
ABSOLUTE .035 SELF-EXPANDING BILIARY STENT SYSTEM
K033393 · FGE
Guidant Corp.
Gastroenterology & Urology · 18d
Cleared Aug 26, 2003
HI-TORQUE BALANCE INIVERSAL GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING
K031678 · DQX
Guidant Corp.
Cardiovascular · 88d
Cleared Jul 23, 2003
RAPIDO CUT-AWAY CUTTER
K031459 · DQY
Guidant Corp.
Cardiovascular · 76d
Cleared May 20, 2003
IS-1 HEMOSTASIS VALVE, MODEL 6799
K031398 · DTL
Guidant Corp.
Cardiovascular · 15d
Cleared May 14, 2003
GUIDANT VASOVIEW ENDOSCOPIC VESSEL HARVESTING SYSTEM
K030512 · GCJ
Guidant Corp.
General & Plastic Surgery · 84d
Cleared Jan 24, 2003
MODIFICATION TO HI-TORQUE WHISPER GUIDEWIRE
K030019 · DQX
Guidant Corp.
Cardiovascular · 21d
Cleared Dec 10, 2002
AGILTRAC .035 PERIPHERAL DILATATION CATHETER
K023320 · DQY
Guidant Corp.
Cardiovascular · 67d
Cleared Nov 12, 2002
ESSEX ENDOSCOPE, MODEL SXD-1000
K023627 · GCJ
Guidant Corp.
General & Plastic Surgery · 15d
Cleared Oct 28, 2002
HI-TORQUE WHISPER LS
K023300 · DQX
Guidant Corp.
Cardiovascular · 25d
Cleared Sep 13, 2002
GUIDANT PROXIMAL SEAL SYSTEM, MODELS PSS-4500 & PS-4500
K022880 · DXC
Guidant Corp.
Cardiovascular · 14d
Cleared Sep 13, 2002
AGILTRAC .035 PERIPHERAL DILATATION CATHETER
K022738 · DQY
Guidant Corp.
Cardiovascular · 25d
Cleared Aug 02, 2002
RAPIDO GUIDING CATHETER, 6F MODEL# 6776
K021455 · DQY
Guidant Corp.
Cardiovascular · 88d
Cleared Jul 02, 2002
DYNALINK .035 BILIARY SELF-EXPANDING STENT SYSTEM, MODELS...
K021824 · FGE
Guidant Corp.
Gastroenterology & Urology · 28d
Cleared May 15, 2002
HI-TORQUE BALANCE, BALANCE MIDDLEWEIGHT, BALANCE HEAVYWEIGHT, BALANCE TREK...
K021228 · DQX
Guidant Corp.
Cardiovascular · 27d
Cleared May 02, 2002
HI-TORQUE EXTRA S'PORT GUIDEWIRE
K021285 · DQX
Guidant Corp.
Cardiovascular · 14d
Cleared May 02, 2002
EASYTRAK GUIDING CATHETER
K021284 · DQY
Guidant Corp.
Cardiovascular · 14d
Cleared May 02, 2002
GUIDANT BALLOON CATHETER, SEVERAL MODELS
K021283 · DQO
Guidant Corp.
Cardiovascular · 14d
Cleared May 02, 2002
LV-1 HEMOSTASIS VALVE, MODEL #6789
K021282 · DTL
Guidant Corp.
Cardiovascular · 14d
Cleared Mar 01, 2002
MODIFICATION TO HI-TORQUE WHISPER LS AND MS GUIDE WIRES WITH HYDROCOAT...
K020340 · DQX
Guidant Corp.
Cardiovascular · 28d