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 3 of 9
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K162467 | Twin-Pass Torque | Vascular Solutions, Inc. | 2017-02-01 | Traditional | PDF ↗ |
| K162253 | Trapper Exchange Device | Creganna Medical Aslo Business AS Cregganna Tactx Medical | 2017-01-06 | Traditional | PDF ↗ |
| K162563 | YOGA Microcatheter | Codman & Shurtleff, Inc. | 2017-01-05 | Special | PDF ↗ |
| K163000 | AMPLATZER TorqVue 45x45 Delivery Sheath | Aga Medical COrporation (Wholly Owned by St. Jude Medical CO | 2016-12-23 | Special | PDF ↗ |
| K160561 | Boosting Catheter | Qxmedical, LLC | 2016-11-02 | Traditional | PDF ↗ |
| K161546 | R2P SlenGuide | Ashitaka Factory of Terumo Corporation | 2016-10-14 | Traditional | PDF ↗ |
| K161152 | Navien Intracranial Support Catheter | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2016-10-12 | Traditional | PDF ↗ |
| K162384 | TrailBlazer Angled Support Catheter | Medtronic Vascular, Inc.(Formerly Ev3 Inc.) | 2016-09-22 | Traditional | PDF ↗ |
| K162359 | Surefire Guiding Catheter | Surefire Medical, Inc. | 2016-09-21 | Special | PDF ↗ |
| K161262 | Super Distal Access (SDA) | Inneuroco, Inc. | 2016-09-19 | Traditional | PDF ↗ |
| K162228 | TorqVue Low Profile Delivery Catheter | Aga Medical Corporation (Wholly Owned by St.Jude Medical Cor | 2016-09-09 | Special | PDF ↗ |
| K161126 | ASAHI Corsair Pro | Asahi Intecc Co., Ltd. | 2016-08-25 | Traditional | PDF ↗ |
| K161986 | SIDEKICK and USHER Support Catheters | Bard Peripheral Vascular, Inc. | 2016-08-04 | Special | PDF ↗ |
| K160848 | Wingman 18 Crossing Catheter | Reflow Medical, Inc. | 2016-07-14 | Traditional | PDF ↗ |
| K160448 | ARTLINE | Health Line International Corporation | 2016-07-12 | Traditional | PDF ↗ |
| K160681 | CenterCross Ultra Catheter | Roxwood Medical, Inc. | 2016-06-17 | Special | PDF ↗ |
| K161362 | ASAHI Corsair Armet | Asahi Intecc Co., Ltd. | 2016-06-14 | Special | PDF ↗ |
| K153703 | Guiding Catheter | Texasmedical Technologies, Inc. | 2016-05-12 | Traditional | PDF ↗ |
| K160389 | NovaCross Microcatheter | Nitiloop , Ltd. | 2016-03-11 | Special | PDF ↗ |
| K152957 | MultiCross Catheter | Roxwood Medical, Inc. | 2016-03-04 | Special | PDF ↗ |
| K152249 | ASAHI Corsair Armet | Asahi Intecc Co., Ltd. | 2016-03-04 | Traditional | PDF ↗ |
| K153729 | 8F FlowGate2 Balloon Guide Catheter | Concentric Medical | 2016-01-27 | Special | PDF ↗ |
| K152456 | CenterCross Ultra Catheter | Roxwood Medical, Inc. | 2016-01-26 | Traditional | PDF ↗ |
| K152447 | ASAHI Caravel | Asahi Intecc Co., Ltd. | 2016-01-22 | Traditional | PDF ↗ |
| K152876 | LONG SHEATH OR LS, 70 CM, LONG SHEATH OR LS, 80 CM, LONG SHEATH OR LS, 90 CM | Tni Manufacturing, Inc. | 2016-01-08 | Traditional | PDF ↗ |
| K152202 | Intermediate Catheter, 105 cm, Intermediate Catheter, 115cm, Intermediate Catheter , 125cm | Tni Manufacturing, Inc. | 2015-12-14 | Traditional | PDF ↗ |
| K151396 | MIVI Mi-AXUS Guide Catheter | Mivi Neuroscience, Inc. | 2015-12-09 | Traditional | PDF ↗ |
| K151896 | Houdini Catheter | Cruzar Medsystems, Inc. | 2015-12-07 | Traditional | PDF ↗ |
| K152401 | Stingray LP Catheter | Boston Scientific Corporation | 2015-12-04 | Traditional | PDF ↗ |
| K152840 | Lantern Delivery Microcatheter | Penumbra, Inc. | 2015-12-02 | Special | PDF ↗ |
| K151638 | Phenom 17 Catheter, Phenom 21 Catheter, Phenom 27 Catheter, Phenom Plus Catheter | Cathera, Inc. | 2015-11-13 | Traditional | PDF ↗ |
| K151667 | AXS Catalyst Distal Access Catheter 058x115cm, AXS Catalyst Distal Access Catheter 058x132cm, AXS Catalyst Distal Access Catheter 060x132cm | Stryker | 2015-11-13 | Traditional | PDF ↗ |
| K151821 | ER-REBOA Catheter | Pryor Medical Devices, Inc. | 2015-10-23 | Traditional | PDF ↗ |
| K150894 | VIA 21 Microcatheter | Sequent Medical, Inc. | 2015-08-28 | Traditional | PDF ↗ |
| K151981 | Turnpike catheter | Vascular Solution, Inc. | 2015-08-13 | Special | PDF ↗ |
| K151880 | Wingman Crossing Catheter | Reflow Medical | 2015-08-07 | Special | PDF ↗ |
| K151409 | Selectra Catheters and Selectra Accessory Kit | Biotronik, Inc. | 2015-08-07 | Special | PDF ↗ |
| K150865 | Metacross RX PTA Balloon Dilitation Catheter | KANEKA Corporation | 2015-08-03 | Traditional | PDF ↗ |
| K150107 | Arc Intracranial Support Catheter, Arc Mini Intracranial Support Catheter | Micro Therapeutics Inc Dba Ev3 Neurovascular | 2015-07-29 | Traditional | PDF ↗ |
| K151103 | ASAHI Corsair Microcatheter | Asahi Intecc Co., Ltd. | 2015-06-23 | Traditional | PDF ↗ |
| K151082 | MicroCross Catheter | Roxwood Medical, Inc. | 2015-06-07 | Special | PDF ↗ |
| K150970 | Coda LP Balloon Catheter | Cook Incorporated | 2015-05-12 | Special | PDF ↗ |
| K143608 | NovaCross Microcatheter | Nitiloop , Ltd. | 2015-05-04 | Traditional | PDF ↗ |
| K143744 | MicroCross Catheter | Roxwood Medical, Inc. | 2015-04-14 | Traditional | PDF ↗ |
| K143459 | Silk Road Acccess Catheter | Silk Road Medical, Inc. | 2015-04-01 | Traditional | PDF ↗ |
| K150366 | SOFIA 6F Catheter | MicroVention, Inc. | 2015-03-27 | Special | PDF ↗ |
| K142449 | Headway 27 Microcatheter | MicroVention, Inc. | 2015-03-26 | Special | PDF ↗ |
| K141981 | ASAHI FUBUKI 043 / ASAHI FUBUKI | Asahi Intecc Co., Ltd. | 2015-03-09 | Traditional | PDF ↗ |
| K150201 | Quick-Cross Extreme Support Catheter, Quick-Cross Select Support Catheter | Spectranetics, Inc. | 2015-02-27 | Special | PDF ↗ |
| K141354 | NAVAJO PTA BALLOON DILATATION CATHETER | Curative Medical, Inc. | 2015-01-30 | Traditional | PDF ↗ |
| K142321 | Benchmark Intracranial Access System | Penumbra, Inc. | 2015-01-26 | Traditional | PDF ↗ |
| K143412 | ADROIT Guiding Catheter | Cordis Corporation | 2015-01-14 | Special | PDF ↗ |
| K142235 | CPS Aim MediGuide Enabled inner catheter, CPS Aim Mediguide Enabled inner Catheter | St Jude Medical | 2014-12-18 | Traditional | PDF ↗ |
| K142239 | CPS Direct MediGuide Enabled outer catheter | St Jude Medical | 2014-12-18 | Traditional | PDF ↗ |
| K141529 | ALVIGUIDE BLUE+ INTERVENTIONAL CARDIOLOGY GUIDING CATHETER | Alvimedica Tibbi Urunler Sanayi VE Dis Ticaret A.S | 2014-12-03 | Traditional | PDF ↗ |
| K142065 | TURNPIKE CATHETER | Vascular Solutions, Inc. | 2014-11-25 | Traditional | PDF ↗ |
| K140910 | CENTERCROSS CATHETER | Roxwood Medical, Inc. | 2014-11-19 | Traditional | PDF ↗ |
| K142565 | Excelsior XT-17 Microcatheter, Excelsior XT-17 Flex Microcatheter, Excelsior XT-17 Pre-Shaped Microcatheter, Excelsior XT-17 Flex Pre-Shaped Microcatheter | Stryker Neurovascular | 2014-11-14 | Special | PDF ↗ |
| K141649 | SPEX SUPPORT CATHETER | Reflow Medical | 2014-11-05 | Traditional | PDF ↗ |
| K142014 | SOFIA DISTAL ACCESS CATHETER | MicroVention, Inc. | 2014-10-10 | Special | PDF ↗ |
| K141547 | WINGMAN EXTENDABLE TIP SUPPORT CATHETER | Reflow Medical | 2014-09-30 | Traditional | PDF ↗ |
| K140557 | MIVI 6F GUIDE CATHETER | Mivi, LLC | 2014-09-18 | Traditional | PDF ↗ |
| K140080 | ENVOY DISTAL ACCESS (DA) GUIDING CATHETER, 6F, 95CM & 105CM, STRAIGHT & XB, MPD & XB, MPC & XB | Codman & Shurtleff, Inc. | 2014-04-24 | Special | PDF ↗ |
| K140307 | ENVOY GUIDING CATHETER | Codman & Shurtleff, Inc. | 2014-04-21 | Special | PDF ↗ |
| K132914 | ACUITY PRO LEAD DELIVERY SYSTEM | Boston Scientific | 2014-04-03 | Traditional | PDF ↗ |
| K133539 | TOTAL ACROSS | Medtronic Vascular | 2014-03-26 | Traditional | PDF ↗ |
| K140034 | SUREFIRE GUIDING CATHETER | Surefire Medical, Inc. | 2014-02-26 | Traditional | PDF ↗ |
| K133177 | MODIFIED HD GUIDE CATHETER | Concentric Medical, Inc. | 2014-02-25 | Traditional | PDF ↗ |
| K133501 | LEADLINER CS LEAD DELIVERY SYSTEM | Vascular Solutions, Inc. | 2014-02-25 | Traditional | PDF ↗ |
| K131592 | ENLIGHTN RENAL GUIDE CATHETER | St. Jude Medical, Inc. | 2014-01-31 | Traditional | PDF ↗ |
| K131204 | ADVANCE CS CORONARY SINUS INFUSION CATHETER | Cook, Inc. | 2014-01-29 | Traditional | PDF ↗ |
| K133026 | UNBALLOON NON-OCCLUSION MODELING CATHETER | LeMaitre Vascular, Inc. | 2013-12-31 | Traditional | PDF ↗ |
| K132652 | VIA MICROCATHETER, VIA PLUS MICROCATHETER | Sequent Medical, Inc. | 2013-12-20 | Traditional | PDF ↗ |
| K131482 | SOFIA DISTAL ACCESS CATHETER | MicroVention, Inc. | 2013-11-22 | Traditional | PDF ↗ |
| K132542 | TRANSGATE GUIDE CATHETER | Stryker Neurovascular | 2013-11-15 | Traditional | PDF ↗ |
| K130649 | SILK ROAD ACCESS CATHETER | Silk Road Medical, Inc. | 2013-11-01 | Traditional | PDF ↗ |
| K132556 | SHEATHLESS EAUCATH CORONARY GUIDE CATHETER | Asahi Intecc Co., Ltd. | 2013-10-24 | Traditional | PDF ↗ |
| K132673 | 5F & 6F LAUNCHER GUIDE CATHETER, 5F SHERPA ACTIVE NX GUIDE CATHETER, 6F Z4 GUIDING CATHETER | Medtronic, Inc. | 2013-10-22 | Special | PDF ↗ |
| K130378 | RESPIGUIDE DELIVERY SYSTEM | Respicardia | 2013-10-17 | Traditional | PDF ↗ |
| K130858 | REVERSE MEDICAL MICROCATHETER | Reverse Medical Corporation | 2013-10-11 | Traditional | PDF ↗ |
| K130525 | OCCLUSION PERFUSION CATHETER | Advanced Catheter Therapies, Inc. | 2013-10-03 | Traditional | PDF ↗ |
| K131492 | MODIFIED FLOWGATE BALLOON GUIDE CATHETER | Concentric Medical, Inc. | 2013-10-03 | Traditional | PDF ↗ |
| K132659 | VOLCANO PREVIEW FORWARD-LOOKING IVUS SYSTEM | Volcano Corporation | 2013-09-27 | Special | PDF ↗ |
| K132701 | PRIMI SUPPORT CATHETER | Thermopeutix, Inc. | 2013-09-26 | Special | PDF ↗ |
| K132420 | WINGMAN EXTENDABLE TIP SUPPORT CATHETER | Reflow Medical | 2013-09-19 | Special | PDF ↗ |
| K132409 | CONCIERGE GUIDING CATHETER | Merit Medical Systems, Inc. | 2013-08-29 | Special | PDF ↗ |
| K131978 | SELECTRA ACCESSORY KIT, SELECTRA SLITTER TOOL | Biotronik, Inc. | 2013-08-23 | Special | PDF ↗ |
| K130714 | PROGIGY SUPPORT CATHETER | Radius Medical, LLC | 2013-08-22 | Abbreviated | PDF ↗ |
| K131063 | AMPLATZER TORQ VUE LP DELIVERY SYSTEM | St Jude Medical | 2013-08-15 | Traditional | PDF ↗ |
| K132197 | CONVEY 7F GUIDING CATHETER, CONVEY 8F GUIDING CATHETER | Pendracare International, B.V. | 2013-08-12 | Special | PDF ↗ |
| K131493 | SIDEKICK AND USHER SUPPORT CATHETERS | C.R. Bard, Inc. | 2013-08-02 | Traditional | PDF ↗ |
| K122917 | CODA BALLOON CATHETER | Cook, Inc. | 2013-06-28 | Special | PDF ↗ |
| K130850 | PRIMI AND SECONDI SUPPORT CATHETERS | Thermopeutix, Inc. | 2013-06-25 | Traditional | PDF ↗ |
| K131225 | ADROIT GUIDING CATHETER | Cordis Corp., A Johnson & Johnson Co. | 2013-05-29 | Special | PDF ↗ |
| K122826 | PREVIEW FORWARD-LOOKING IVUS CATHETER AND LAPTOP SYSTEM; PREVIEW CATHETER MODEL 87000; PIMF MODEL 87-PIMF; LAPTOP SYSTEM | Volcano Corporation | 2013-04-24 | Traditional | PDF ↗ |
| K123153 | ATTAIN COMMAND+SUREVALVE LEFT HEART DELIVERY SYSTEM ATTAIN COMMAND GUIDE CATHETERS FOR LEFT HEART DELIVERY,ATTAIN SELECT | Medtronic, Ireland | 2013-04-09 | Traditional | PDF ↗ |
| K130252 | CPS AIM UNIVERSAL SLITTABLE INNER CATHETER | St Jude Medical | 2013-03-20 | Traditional | PDF ↗ |
| K130257 | CPS DIRECT UNIVERSAL SLITTABLE OUTER CATHETER | St Jude Medical | 2013-03-20 | Traditional | PDF ↗ |
| K122940 | ADVANCE MICRO 14 ULTRA LOW PROFILE BALLOON DILATATION CATHETER MODEL PTA3 | Cook, Inc. | 2013-03-19 | Traditional | PDF ↗ |
| K123765 | GUIDEZILLA GUIDE EXTENSION CATHETER | Boston Scientific | 2013-03-19 | Traditional | PDF ↗ |
Product code DQY · Class II · Cardiovascular. Data: openFDA.