FDA Product Code
FDA Product Code DQY — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.1250
510(k) Clearances — 896 records · page 4 of 9
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K123311 | QXMEDICAL ACCESS & SUPPORT CATHETER | Qxmedical, LLC | 2013-01-14 | Traditional | PDF ↗ |
| K123324 | SELECTRA 7F CATHETERS | Biotronik, Inc. | 2013-01-11 | Special | PDF ↗ |
| K123452 | TRACKER-17 MICROCATHER, 150 CM LONG AND 15.0 CM FLEXIBLE DISTAL SHAFT, TRACKER-17 MICROCATHETER, 150 CM LONG AND 7.5 CM | Stryker | 2013-01-03 | Special | PDF ↗ |
| K121077 | NHANCER | Imds Operations B.V. | 2012-12-21 | Traditional | PDF ↗ |
| K123531 | UNBALLOON NON-OCCLUSIVE MODELING CATHETER | LeMaitre Vascular, Inc. | 2012-12-14 | Special | PDF ↗ |
| K122684 | REVERSE MEDICAL MICROCATHETER | Reverse Medical Corporation | 2012-12-07 | Traditional | PDF ↗ |
| K121763 | MULTICROSS SUPPORT CATHETER | Roxwood Medical, Inc. | 2012-11-27 | Traditional | PDF ↗ |
| K122581 | MODIFIED BALLOON GUIDE CATHETER MODEL 90253, 90254 | Concentric Medical, Inc. | 2012-11-21 | Traditional | PDF ↗ |
| K122772 | PENUMBRA DDC CATHETERS | Penumbra, Inc. | 2012-11-20 | Traditional | PDF ↗ |
| K121219 | ATTAIN CLARITY 6225 VENOGRAM BALLOON CATHETER | Medtronic, Inc. | 2012-09-25 | Traditional | PDF ↗ |
| K121859 | TYSHAK NUCLEUS | NuMED, Inc. | 2012-08-31 | Special | PDF ↗ |
| K122394 | RUBICON 18 SUPPORT CATHETER | Boston Scientific Corp | 2012-08-30 | Special | PDF ↗ |
| K121611 | AMPLATZER TORQVUE FX | Aga Medical Corporation | 2012-08-23 | Traditional | PDF ↗ |
| K121352 | ARMADA 14XXT PTA CATHETER | Abbott Vascular | 2012-08-15 | Traditional | PDF ↗ |
| K120781 | CELLO BALLOON GUIDE CATHETER (6F), 950 MM AND 1020 MM LENGTH | Fuji Systems Corp. | 2012-08-09 | Traditional | PDF ↗ |
| K121839 | UNBALLOON NON-OCCLUSIVE MODELING CATHETER | LeMaitre Vascular, Inc. | 2012-08-08 | Special | PDF ↗ |
| K120585 | CONVEY GUIDING CATHETER | Pendracare International, B.V. | 2012-08-08 | Traditional | PDF ↗ |
| K121051 | CONCIERGE GUIDING CATHETER | Merit Medical Systems, Inc. | 2012-06-13 | Special | PDF ↗ |
| K120964 | UPSTREAM GR CATHETER | Upstream Peripheral Technologies | 2012-05-25 | Traditional | PDF ↗ |
| K120707 | SWITCH-IT CATHETER | Vascular Solutions, Inc. | 2012-05-15 | Traditional | PDF ↗ |
| K120296 | CPS DIRECT MEDIGUIDE ENABLED OUTER CATHETER | St. Jude Medical, Cardiac Rhythm Management Divisi | 2012-05-11 | Traditional | PDF ↗ |
| K113778 | EXCELSIOR XT-27 MICROCATHETER | Stryker Neurovascular | 2012-04-20 | Traditional | PDF ↗ |
| K112100 | M2 NAVIGATION CATHETER AND GUIDELINER NAVIGATION CATHETER | Vascular Solutions, Inc. | 2012-03-20 | Traditional | PDF ↗ |
| K120120 | AMPLATZER TORQVUE 45X45 DELIVERY SHEATH AMPLATZER TORQVUE LA1 DELIVERY SHEATH AMPLATZER TORQVUE LA2 SELIVERY SHEATH | Aga Medical Corporation | 2012-03-15 | Special | PDF ↗ |
| K112404 | CONCENTRIC BALLOON GUIDE CATHETER | Concentric Medical, Inc. | 2012-03-15 | Traditional | PDF ↗ |
| K120229 | ENVOY DISTAL ACCESS GUIDING CATHETER | Codman & Shurtleff, Inc. | 2012-02-24 | Special | PDF ↗ |
| K120381 | Q50 PLUS STENT GRAFT BALLOON CATHETER | Qxmedical, LLC | 2012-02-24 | Traditional | PDF ↗ |
| K112886 | UPSTREAM SUPPORT CATHETER | Upstream Peripheral Technologies | 2012-02-23 | Traditional | PDF ↗ |
| K120178 | WINGMAN EXTENDABLE TIP SUPPORT CATHETER | Reflow Medical | 2012-02-08 | Special | PDF ↗ |
| K120129 | MANTARAY CATHETER | Bridgepoint Medical | 2012-02-03 | Special | PDF ↗ |
| K102439 | FUNNEL GUIDE CATHETER MODEL G1020608 | Lazarus Effect, Inc. | 2012-01-12 | Traditional | PDF ↗ |
| K112035 | VALET MICRO CATHETER | Volcano Corporation | 2012-01-05 | Traditional | PDF ↗ |
| K113589 | BIGBOSS CATHETER | Bridgepoint Medical | 2012-01-04 | Special | PDF ↗ |
| K111738 | CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) GUIDE WIRE (0.014 AND 0.018) | Trireme Medical, Inc. | 2011-12-14 | Special | PDF ↗ |
| K112082 | GUIDELINER V2 CATHETER | Vascular Solutions, Inc. | 2011-12-01 | Special | PDF ↗ |
| K113112 | CLEARWAY RX NB CATHETER | Atrium Medical Corp. | 2011-11-17 | Special | PDF ↗ |
| K112303 | RUBICON SUPPORT CATHETER | Boston Scientific | 2011-11-09 | Traditional | PDF ↗ |
| K112262 | REFLEX BALLON GUIDE CATHETER | Reverse Medical Corporation | 2011-11-02 | Traditional | PDF ↗ |
| K112917 | ATTAIN LDS 6216A LEFT HEART DELIVERY SYSTEM, ATTAIN ACCESS 6218A LEFT HEART DELIVERY SYSTEM, ATTAIN 6216A AND 6218A GUID | Medtronic, Inc. | 2011-10-27 | Special | PDF ↗ |
| K112828 | REVIVE INTERMEDIATE CATHETER (REVIVE IC) | Codman & Shurtleff, Inc. | 2011-10-25 | Special | PDF ↗ |
| K112032 | 8FR TURBO - TANDEM SYSTEM | Spectranetics Corp. | 2011-10-17 | Traditional | PDF ↗ |
| K112335 | BANTAM CATHETER (280MM BALLOON LENGTHS) | ClearStream Technologies , Ltd. | 2011-10-12 | Traditional | PDF ↗ |
| K112629 | ONSET ACCESS CATHETER SYSTEM | Onset Medical Corporation | 2011-10-11 | Traditional | PDF ↗ |
| K112579 | WILDCAT 5F GUIDEWIRE SUPPORT CATHETER | Avinger, Inc. | 2011-10-06 | Special | PDF ↗ |
| K112482 | SELECTRA SLITTER TOOL | Biotronik, Inc. | 2011-09-26 | Special | PDF ↗ |
| K111839 | SELECTRA ACCESSORY KIT | Biotronik, Inc. | 2011-09-26 | Traditional | PDF ↗ |
| K110891 | THE UNBALLOON NON-OCCLUSIVE CATHETER; THE UNBALLOON NON-OCCLUSIVE MODELING CATHETER | LeMaitre Vascular, Inc. | 2011-09-13 | Traditional | PDF ↗ |
| K111704 | AVINGER WILDCAT 6F GUIDEWIRE SUPPORT CATHETER AND JUICEBOX | Avinger, Inc. | 2011-09-09 | Traditional | PDF ↗ |
| K112281 | GLIDERXTREME PTA BALLON CATHETER (OVER THE WIRE) 0.018 GUIDE WIRE 6100-XXXXX, 6100CB-XXXX | Trireme Medical, Inc. | 2011-08-17 | Traditional | PDF ↗ |
| K111963 | BRIDGEPOINT MEDICAL MANTARAY(TM) CATHETER | Bridgepoint Medical | 2011-08-10 | Special | PDF ↗ |
| K110813 | HEADWAY 27 MICROCATHETER | MicroVention, Inc. | 2011-08-05 | Special | PDF ↗ |
| K111334 | BENELLI ACCESS DEVICE | Vascular Solutions, Inc. | 2011-08-01 | Traditional | PDF ↗ |
| K111556 | GLIDECROSS SUPPORT CATHETER | Terumo Medical Corp. | 2011-07-29 | Traditional | PDF ↗ |
| K111750 | EXTRA PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE; PROTEUS PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE | Angioslide, Ltd. | 2011-07-21 | Special | PDF ↗ |
| K111380 | NEURON MAX SYSTEM | Penumbra, Inc. | 2011-07-19 | Special | PDF ↗ |
| K111850 | VACCESS PTA DILATATION CATHETER | C.R. Bard, Inc. | 2011-07-13 | Traditional | PDF ↗ |
| K111252 | ACUITY (TM) CUT-AWAY (TM) GUIDE CATHETERS 6F AND 8F | Boston Scientific Corp | 2011-06-02 | Special | PDF ↗ |
| K111154 | SELECTRA IC-50-60, SELECTRA IC-50-75, SELECTRA IC-90-65, SELECTRA IC-90-75 | Biotronik, Inc. | 2011-05-23 | Special | PDF ↗ |
| K110540 | TERUMO SUPPORT CATHETER | Terumo Medical Corp. | 2011-05-13 | Traditional | PDF ↗ |
| K102725 | CROSSBOSS CATHETER MODEL M-2000, STINGRAY ORIENTING BALLOON CATHETER MODEL M-1000, STINGRAY GUIDEWIRE MODEL M-3004 AND M | Bridge Medical, Inc. | 2011-05-10 | Traditional | PDF ↗ |
| K110461 | SELECTRA CS LEAD INTRODUCER SYSTEM | Biotronik, Inc. | 2011-04-20 | Special | PDF ↗ |
| K102418 | REVERSE MEDICAL REPORT GUIDE CATHETER SYSTEM | Reverse Medical Corporation | 2011-04-15 | Traditional | PDF ↗ |
| K110055 | REVERSE MEDICAL REFLEX GUIDE CATHETER | Reverse Medical Corporation | 2011-04-05 | Traditional | PDF ↗ |
| K110483 | MODIFIED HD GUIDE CATHETER | Concentric Medical, Inc. | 2011-04-04 | Special | PDF ↗ |
| K100184 | FUSTAR STEERABLE INTRODUCERS | Lifetech Scientific (Shenzhen) Co., Ltd. | 2011-02-14 | Traditional | PDF ↗ |
| K103386 | MEDTRONIC VASCULAR - HUB MATERIAL MODIFICATION TO THE 5F AND 8F LAUNCHER(R) GUIDE CATHETERS | Medtronic, Inc. | 2011-02-11 | Special | PDF ↗ |
| K103250 | CPS DIRECT SL II SLITTABLE OUTER CATHETER | St. Jude Medical, Cardiac Rhythm Management Divisi | 2011-01-19 | Special | PDF ↗ |
| K102979 | NEXGEN PERIPHERAL GUIDE CATHETER | Nexgen Medical Systems, Inc. | 2011-01-18 | Traditional | PDF ↗ |
| K103534 | GLIDERXTREME PTA BALLOON CATHETER (CB) (OVER THE WIRE) 0.014 / 0.018 GUIDE WIRE | Trireme Medical, Inc. | 2011-01-05 | Traditional | PDF ↗ |
| K101659 | SUPERCROSS MICROCATHETER (130 CM), SUPERCROSS MICROCATHETER (150 CM) MODEL 5300, 5301 | Vascular Solutions, Inc. | 2010-12-16 | Traditional | PDF ↗ |
| K103367 | SEEKER CROSSING SUPPORT CATHETER | Bard Peripheral Vascular, Inc. | 2010-12-08 | Traditional | PDF ↗ |
| K102657 | CONCENTRIC BALLOON GUIDE CATHETER | Concentric Medical, Inc. | 2010-11-17 | Traditional | PDF ↗ |
| K101015 | GUIDE CATHETERS AND ACCESSORIES | Thomas Medical Products, Inc. | 2010-09-23 | Traditional | PDF ↗ |
| K101885 | MEDTRONIC C315 DELIVERY CATHETER | Medtronic, Inc. | 2010-09-09 | Special | PDF ↗ |
| K101479 | WINGMAN EXTENDABLE TIP SUPPORT CATHETER | Reflow Medical | 2010-08-11 | Traditional | PDF ↗ |
| K101542 | HEADWAY 17 ADVANCED MICROCATHETER | MicroVention, Inc. | 2010-08-06 | Traditional | PDF ↗ |
| K102022 | WILDCAT 6F GUIDEWIRE SUPPORT CATHETER MODEL W400L AND W400S | Avinger, Inc. | 2010-08-06 | Special | PDF ↗ |
| K101877 | OCCLUSION BALLOON CATHETER MODEL OBC | Cook, Inc. | 2010-08-06 | Special | PDF ↗ |
| K101591 | STINGRAY ORIENTING BALLOON CATHETER | Bridgepoint Medical | 2010-08-06 | Special | PDF ↗ |
| K101647 | WILDCAT 5F GUIDEWIRE SUPPORT CATHETER, MODE W500 | Avinger, Inc. | 2010-08-06 | Special | PDF ↗ |
| K101776 | SCOUTPRO ACS | Biotronik, Inc. | 2010-07-23 | Special | PDF ↗ |
| K101282 | SCOUTPRO HEMOSTATIC VALVE | Biotronik, Inc. | 2010-07-21 | Special | PDF ↗ |
| K101117 | LEV-OR DILATION CATHETER OTW | Baylis Medical Co., Inc. | 2010-07-16 | Traditional | PDF ↗ |
| K100826 | PENUMBRA CATHERER 025 | Penumbra, Inc. | 2010-07-13 | Traditional | PDF ↗ |
| K093977 | ALLIGATOR-HD RETRIEVAL DEVICE (ARD-HD), MODEL FA-88840-XX | Chestnut Medical Technologies, Inc. | 2010-04-22 | Traditional | PDF ↗ |
| K093431 | CLEARWAY OTW MODEL 85912 | Atrium Medical Corp. | 2010-04-20 | Traditional | PDF ↗ |
| K100135 | GDS-DC12 | Guided Delivery Systems | 2010-04-16 | Traditional | PDF ↗ |
| K093969 | ACUITY BREAK-AWAY GUIDE CATHETER | Cardiac Pacemakers, Inc. | 2010-03-05 | Special | PDF ↗ |
| K091188 | ASAHI ZENYTEEX GUIDING CATHETER | Asahi Intecc Co., Ltd. | 2010-02-26 | Traditional | PDF ↗ |
| K094019 | GLIDER PTA BALLOON CATHETER | Trireme Medical, Inc. | 2010-02-12 | Traditional | PDF ↗ |
| K093476 | AMPLATZER TORQ VUE 2 DELIVERY SHEATH MODEL 9-TV2-05F120, MODEL 9-TV2-06F120, MODELTV-2-07F120 | Aga Medical Corp. | 2010-02-05 | Traditional | PDF ↗ |
| K092174 | ENABLER-P CATHETER SYSTEM, MODEL 3000 | Endocross, Ltd. | 2009-12-30 | Traditional | PDF ↗ |
| K093050 | ARROW SELDINGER ARTERIAL CATHERIZATION DEVICES, MODELS EX SAC 00520 | Arrow Intl., Inc. | 2009-12-18 | Special | PDF ↗ |
| K093303 | SCOUTPRO 7F LONG CATHETERS | Biotronik, Inc. | 2009-11-20 | Special | PDF ↗ |
| K093184 | ENVOY GUIDING CATHETERS | Codman & Shurtleff, Inc. | 2009-11-06 | Special | PDF ↗ |
| K093160 | HEADWAY 21 MICROCATHETER, MODEL: MC212150S | MicroVention, Inc. | 2009-11-05 | Special | PDF ↗ |
| K092298 | MODIFICATION TO MODIFIED HD GUIDE CATHETER | Concentric Medical, Inc. | 2009-11-05 | Special | PDF ↗ |
| K091750 | GUIDELINER CATHETER, MODELS 5571, 5572, 5573 | Vascular Solutions, Inc. | 2009-11-04 | Traditional | PDF ↗ |
| K091624 | STENT GRAFT BALLOON CATHETER | Via Biomedical, Inc. | 2009-10-15 | Traditional | PDF ↗ |
| K092396 | SPECTRANETICS QUICK CROSS EXTREME SUPPORT CATHETERS | Spectranetics Corp. | 2009-09-04 | Special | PDF ↗ |
Product code DQY · Class II · Cardiovascular. Data: openFDA.