FDA Product Code
FDA Product Code DQO — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.1200
510(k) Clearances — 501 records · page 2 of 6
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K090040 | RADIFOCUS GLIDECATH (OR RADIFOCUS GLIDECATH XP) | Terumo Medical Corp. | 2009-02-06 | Traditional | PDF ↗ |
| K081846 | GREBSET MICRO-INTRODUCER KIT, MODELS 7950, 7951 | Vascular Solutions, Inc. | 2009-01-28 | Traditional | PDF ↗ |
| K082736 | RADIFOCUS OPTITORQUE ANGIOGRAPHIC CATHETER | Terumo Medical Corp. | 2008-09-24 | Traditional | PDF ↗ |
| K073585 | INNERCHANGE MICRO-INTRODUCER CATHETER, MODELS 7900, 7901, 7902, 7903, 7904 AND 7905 | Vascular Solutions, Inc. | 2008-04-17 | Traditional | PDF ↗ |
| K073200 | GANDRAS INTRAVASCULAR CATHETER, MODELS 5580, 5581 AND 5582 | Vascular Solutions, Inc. | 2008-02-01 | Traditional | PDF ↗ |
| K072796 | MEERCI RETRIEVER, CONCENTRIC MICROCATHETER, MODELS 90050, 90060, 90065, 90066, 90070,90092, 90043, 90044 | Concentric Medical, Inc. | 2007-12-18 | Special | PDF ↗ |
| K072526 | MICRUS COURIER ENZO MICROCATHETER 0.0190 | Micrus Endovascular Corporation | 2007-10-05 | Special | PDF ↗ |
| K071196 | DISPOSABLE HIGH PRESSURE INJECTION LINES WITH AND WITHOUT ROTATING ADAPTERS | Coeur, Inc. | 2007-09-06 | Traditional | PDF ↗ |
| K070456 | MICRUS COURIER ENZO MICROCATHETER 0.017 | Micrus Endovascular Corporation | 2007-05-24 | Special | PDF ↗ |
| K063784 | DYE MANAGEMENT SYSTEM | Icu Medical, Inc. | 2007-04-16 | Special | PDF ↗ |
| K070011 | IBI INQUIRY CLEARICE INTRACARDIAC ECHOCARDIOGRAPHY ULTRASOUND IMAGING CATHETER | Irvine Biomedical,Inc.(Ibi) | 2007-03-20 | Traditional | PDF ↗ |
| K062877 | TWIN-PASS .023 DUAL ACCESS CATHETER, MODEL 5230 | Vascular Solutions, Inc. | 2007-01-18 | Traditional | PDF ↗ |
| K062627 | INNERCHANGE MICRO-INTRODUCER CATHETER, MODELS 7900 THROUGH 7905 | Vascular Solutions, Inc. | 2007-01-05 | Traditional | PDF ↗ |
| K063312 | MODIFICATION TO ATLANTIS SR PRO 2 AND SR PRO CORONARY IMAGING CATHETERS, MODEL 39014 AND 38942 | Boston Scientific Corp | 2006-11-30 | Special | PDF ↗ |
| K061733 | ANGIODYNAMICS SOFT-VU AND MARINER HYDROPHILIC COATED ANGIOGRAPHIC CATHETER | AngioDynamics, Inc. | 2006-08-24 | Special | PDF ↗ |
| K062126 | EMBOCATH PLUS INFUSION MICROCATHETER, MODEL ECP-100 AND ECP-135 | Biosphere Medical, Inc. | 2006-08-09 | Special | PDF ↗ |
| K060010 | NAUTIFLUX | Sedat | 2006-08-04 | Traditional | PDF ↗ |
| K061963 | MICRUS MICROCATHETER COURIER PRE-SHAPED, MODELS MPS170045-00, MPS170090-00, MPS190045-00, MPS190090-00 | Micrus Endovascular Corporation | 2006-08-04 | Special | PDF ↗ |
| K061565 | LANGSTON DUAL LUMEN CATHETER | Vascular Solutions, Inc. | 2006-08-02 | Traditional | PDF ↗ |
| K052908 | INTRAREDX NIR IMAGING SYSTEM, MODEL MC-5 | Infraredx, Inc. | 2006-06-23 | Traditional | PDF ↗ |
| K060116 | MICRUS COURIER MICROCATHETERS | Micrus Endovascular Corporation | 2006-05-12 | Traditional | PDF ↗ |
| K060175 | ISIGHT IMAGING CATHETER, MODEL 38986 | Boston Scientific Corp | 2006-03-24 | Special | PDF ↗ |
| K052637 | THEROX INFUSION CATHETER, MODEL INCA-1 | Therox, Inc. | 2006-03-08 | Traditional | PDF ↗ |
| K053171 | MERIT IMPRESS DIAGNOSTIC CATHETER | Merit Medical Systems, Inc. | 2006-01-19 | Traditional | PDF ↗ |
| K052865 | HOSPIRA CATH LAB CONVENIENCE KITS | Icu Medical, Inc. | 2005-12-22 | Special | PDF ↗ |
| K051561 | ASAHI ANGIOGRAPHIC CATHETER | Asahi Intecc Co., Ltd. | 2005-11-02 | Traditional | PDF ↗ |
| K050863 | IMAGER II ANGIOGRAPHIC CATHETER | Boston Scientific Corp | 2005-09-02 | Traditional | PDF ↗ |
| K051395 | LANGSTON DUAL LUMEN PRESSURE MONITORING CATHETER | Vascular Solutions, Inc. | 2005-06-24 | Traditional | PDF ↗ |
| K050371 | MEDRAD VANGUARD DX ANGIOGRAPHIC CATHETER | Medrad, Inc. | 2005-06-07 | Traditional | PDF ↗ |
| K050684 | ATLANTIS PV | Boston Scientific Corp | 2005-05-20 | Special | PDF ↗ |
| K050168 | LANGSTON DUAL LUMEN PRESSURE MONITORING CATHETER | Vascular Solutions, Inc. | 2005-05-18 | Traditional | PDF ↗ |
| K050577 | ATLANTIS SR PRO2 CORONARY IMAGING CATHETER, MODEL 39014 | Boston Scientific Corp | 2005-03-30 | Special | PDF ↗ |
| K042685 | METRICATH SYSTEM | Angiometrx, Inc. | 2004-11-18 | Traditional | PDF ↗ |
| K041909 | VASCULAR SOLUTIONS LANGSTON DUAL LUMEN PIGTAIL CATHETER (DLP) | Vascular Solutions, Inc. | 2004-09-23 | Traditional | PDF ↗ |
| K041123 | RINSPIRATION SYSTEM,RINSPIRATION SYSTEM SHORT TIP, MODELS FG01477/FG01703 | Kerberos Proximal Solutions, Inc. | 2004-08-26 | Traditional | PDF ↗ |
| K034043 | H-FLOW VALVE | Elcam Medical Acal | 2004-06-30 | Traditional | PDF ↗ |
| K040830 | PTA, PTV, ATRIOSEPTOSTOMY, ANGIOGRAPHIC, SIZING CATHETERS | NuMED, Inc. | 2004-06-18 | Special | PDF ↗ |
| K041291 | RINSPIRATION SYSTEM | Kerberos Proximal Solutions, Inc. | 2004-05-21 | Special | PDF ↗ |
| K040776 | ATLANTIS SR, MODEL C4020; ATLANTIS SR PLUS, MODEL 35975 | Boston Scientific Corp | 2004-04-29 | Special | PDF ↗ |
| K032888 | CREATION NM DIAGNOSTIC CATHETERS | Neich Medical (Shenzhen) Company Limited | 2004-02-24 | Traditional | PDF ↗ |
| K033583 | PROGREAT | Terumo Medical Corp. | 2003-12-12 | Special | PDF ↗ |
| K031599 | CD LEYCOM PRESSURE/VOLUME CATHETERS | Cd Leycom BV | 2003-12-09 | Special | PDF ↗ |
| K031485 | RINSPIRATION SYSTEM | Kerberos Proximal Solutions | 2003-09-25 | Traditional | PDF ↗ |
| K032624 | MICRUS MICROCATHETER | Micrus Corp. | 2003-09-10 | Traditional | PDF ↗ |
| K032376 | ANGIODYNAMICS ACCU-VU SIZING ANGIOGRAPHIC CATHETER | AngioDynamics, Inc. | 2003-08-26 | Special | PDF ↗ |
| K024000 | METRICATH SYSTEM COMPRISED OF METRICATH 1000 CONSOLE & METRICATH BALLOON CATHETER | Angiometrx, Inc. | 2003-06-26 | Traditional | PDF ↗ |
| K023591 | ULTRA HIGH PRESSURE INJECTOR LINES | Deroyal Industries, Inc. | 2003-06-18 | Traditional | PDF ↗ |
| K022004 | CARDIAC OUTPUT KIT, MODEL CO-1 & INLINE SENSOR CABLE, MODEL ILS-1 | Biosensors International-USA | 2003-03-12 | Traditional | PDF ↗ |
| K024126 | CLEAR OR BRAIDED CONTRAST MEDIA INJECTION LINE OR WITHOUT ROTATOR, CATH LAB KIT | Abbott Laboratories | 2003-01-14 | Special | PDF ↗ |
| K023681 | RENEGADE STC 18 MICROCATHETER | Boston Scientific Corp | 2002-11-26 | Special | PDF ↗ |
| K022621 | BOSTON SCIENTIFIC IMAGER II 4F SELECTIVE ANGIOGRAPHIC CATHETER | Boston Scientific Corp | 2002-09-04 | Special | PDF ↗ |
| K021283 | GUIDANT BALLOON CATHETER, SEVERAL MODELS | Guidant Corp. | 2002-05-02 | Traditional | PDF ↗ |
| K021015 | ACIST PLUS 4 ANGIOGRAPHIC CATHETER | Acist Medical Systems | 2002-04-26 | Special | PDF ↗ |
| K020890 | SPYGLASS 4 FR ANGIOGRAPHICY CATHETER | St Jude Medical | 2002-04-17 | Special | PDF ↗ |
| K020316 | CORDIS TRAPEASE PERMANENT VENA CAVA FILTER WITH THE VISEASE ANGIOGRAPHIC VESSEL DILATOR; MODELS 466-P306AU & 466-P306BU | Cordis Corp. | 2002-03-20 | Traditional | PDF ↗ |
| K012983 | ACIST 4 FRENCH ANGIOGRAPHIC CATHETER | Acist Medical Systems, Inc. | 2002-03-13 | Traditional | PDF ↗ |
| K014054 | EDWARDS LIFESCIENCES SWAN-GANZ MONITORING CATHETER WITH OLIGON MATERIAL | Edwards Lifesciences, LLC | 2002-03-08 | Traditional | PDF ↗ |
| K020012 | MODIFICATION TO RENEGADE FIBER BRAIDED MICROCATHETER | Boston Scientific/Medi-Tech | 2002-01-29 | Special | PDF ↗ |
| K012749 | BIOCARDIA UNIVERSAL DEFLECTABLE GUIDE CATHETER, MODEL 000664 | Biocardia, Inc. | 2002-01-24 | Traditional | PDF ↗ |
| K011664 | IMAGER II ANGIOGRAPHIC CATHETER | Boston Scientific/Medi-Tech | 2001-09-07 | Special | PDF ↗ |
| K003288 | ORIGEN DUAL LUMEN CATHETER | Origen Biomedical, Inc. | 2001-06-08 | Traditional | PDF ↗ |
| K003105 | BIOSPHERE MEDICAL INFUSION CATHETER | Biosphere Medical | 2001-05-22 | Traditional | PDF ↗ |
| K011217 | CLEAR OR BRAIDED CONTRAST MEDIA INJECTION LINE WITH OR WITHOUT ROTATOR, CATH LAB KIT | Abbott Laboratories | 2001-05-16 | Special | PDF ↗ |
| K003086 | CONCENTRIC MICRO CATHETER, MODELS 90001 TO 90008 | Concentric Medical, Inc. | 2001-05-16 | Traditional | PDF ↗ |
| K003020 | CARDIAC FUNCTION LABORATORY; PRESSURE INTERFACE; PRESSURE / VOLUME CATHETER | Cd Leycom BV | 2001-05-11 | Traditional | PDF ↗ |
| K010707 | ATLANTIS SR PLUS CORONARY IMAGING CATHETER, MODEL 35975 | Boston Scientific, Target | 2001-03-29 | Special | PDF ↗ |
| K002254 | COOK PRESSURE MONITORING CATHETER | Cook, Inc. | 2001-03-16 | Traditional | PDF ↗ |
| K003938 | TRAK BACK II | Jomed, Inc. | 2001-01-18 | Special | PDF ↗ |
| K003901 | ANGIODYNAMICS SOFT-VU SIZING ANGIOGRAPHIC CATHETER | AngioDynamics, Inc. | 2001-01-17 | Special | PDF ↗ |
| K003902 | MULTITRACK ANGIOGRAPHIC CATHETER | NuMED, Inc. | 2001-01-11 | Special | PDF ↗ |
| K001578 | ANGIODYNAMICS SOFT-VU HYDROPHILIC COATED ANGIOGRAPHIC CATHETER | AngioDynamics, Inc. | 2000-10-13 | Special | PDF ↗ |
| K000825 | 4F-7F MEDI-DYNE TORQ FLOW XLB ANGIOGRAPHIC CATHETER | Medi-Dyne, Inc. | 2000-09-21 | Traditional | PDF ↗ |
| K002416 | GOLDEN-RULE SCALING CATHETER | Medical Device Technologies, Inc. | 2000-09-11 | Traditional | PDF ↗ |
| K000743 | BOSTON SCIENTIFIC SCIMED ATLANTIS CORONARY IMAGING CATHETER, MODEL C4020 | Boston Scientific Scimed, Inc. | 2000-09-06 | Traditional | PDF ↗ |
| K000820 | AVANAR F/X 2.9F INTRAVASCULAR ULTRASOUND IMAGING CATHETER, MODEL 85700 | Endosonics Corp. | 2000-06-05 | Special | PDF ↗ |
| K000579 | TEMPO AQUA ANGIOGRAPHIC CATHETER | Cordis Corp. | 2000-05-03 | Special | PDF ↗ |
| K000956 | MODIFICATION TO SCIMED 6F IMPULSE ANGIOGRAPHIC CATHATERS | Boston Scientific Scimed, Inc. | 2000-04-21 | Special | PDF ↗ |
| K000659 | MODIFICATION TO SOFTOUCH DIAGNOSTIC INTRAVASCULAR CAT | Merit Medical Systems, Inc. | 2000-03-29 | Special | PDF ↗ |
| K993694 | MIKRO-TIP ANGIOGRAPHIC CATHETER | Millar Instruments, Inc. | 2000-03-01 | Special | PDF ↗ |
| K990173 | PATHFINDER II ANGIOGRAPHIC CATHETER | Maxxim Medical | 1999-12-21 | Traditional | PDF ↗ |
| K992631 | ACUNAV DIAGNOSTIC ULTRASOUND CATHETER | Acuson Corp. | 1999-12-15 | Traditional | PDF ↗ |
| K992347 | CORDIS SUPER TORQUE MB ANGIOGRAPHIC CATHETER WITH RADIOPAQUE MARKER BANDS | Cordis Corp. | 1999-10-08 | Traditional | PDF ↗ |
| K992123 | SCIMED IMPULSE ANGIOGRAPHIC CATHETERS | Boston Scientific Scimed, Inc. | 1999-08-23 | Traditional | PDF ↗ |
| K992051 | RADIFOCUS OPTITORQUE | Terumo Medical Corp. | 1999-08-10 | Special | PDF ↗ |
| K984627 | AVE 4F SITESEER CARDIOVASCULAR ANGIOGRAPHIC CATHETER | Arterial Vascular Engineering, Inc. | 1999-07-27 | Traditional | PDF ↗ |
| K992142 | SCIMED ANGIOGRAPHIC CATHETERS | Scimed | 1999-07-21 | Special | PDF ↗ |
| K991673 | CORDIS TEMPO ANGIOGRAPHY CATHETER | Cordis Corp. | 1999-05-26 | Special | PDF ↗ |
| K984258 | NEUROVASX SUB-MICROINFUSION CATHETER | Neuro Vasx, Inc. | 1999-02-11 | Traditional | PDF ↗ |
| K980973 | MEDTRONIC ANGIOGRAPHIC CATHETER | Medtronics Interventional Vascular | 1998-12-10 | Traditional | PDF ↗ |
| K971616 | BLOOD PRESSURE MEASUREMENT SYSTEM(DSPM-70) | Data Sciences Intl., Inc. | 1998-11-04 | Traditional | PDF ↗ |
| K982299 | SPYGLASS 5 FR ANGIOGRAPHIC CATHETER | Daig Corp. | 1998-10-19 | Traditional | PDF ↗ |
| K974774 | ENVY GUIDING CATHETER | Cook, Inc. | 1998-10-16 | Traditional | PDF ↗ |
| K981788 | SCIMED 6 FRENCH WISEGUIDE GUIDE CATHETER | Scimed Life Systems, Inc. | 1998-08-18 | Traditional | PDF ↗ |
| K982077 | SELECTOR DIAGNOSTIC CATHETER | Boston Scientific Scimed, Inc. | 1998-08-11 | Traditional | PDF ↗ |
| K981441 | HEART CATH TRAY, STERILE, DISPOSABLE | Trinity Laboratories, Inc. | 1998-07-10 | Traditional | PDF ↗ |
| K980575 | SITESEER ANGIOGRAPHIC CATHETER | C.R. Bard, Inc. | 1998-05-15 | Traditional | PDF ↗ |
| K974559 | SCIMED 6 FRENCH IMPULSE ANGIOGRAPHIC CATHETERS | Scimed Life Systems, Inc. | 1998-02-23 | Traditional | PDF ↗ |
| K973401 | TEMPO 4 ANGIOGRAPHY CATHETER (VARIOUS) | Cordis Corp. | 1997-11-18 | Traditional | PDF ↗ |
| K964210 | RETRIEVER II | Target Therapeutics | 1997-10-31 | Traditional | PDF ↗ |
| K962829 | HARMAC BALLOON ANGIOGRAPHIC CATHETER | Harmac Medical Products, Inc. | 1997-10-16 | Traditional | PDF ↗ |
Product code DQO · Class II · Cardiovascular. Data: openFDA.