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 2 of 9
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K203275 | Recon Support Catheter | C.R. Bard, Inc. | 2021-03-01 | Traditional | PDF ↗ |
| K210230 | Phenom Catheters | Micro Therapeutics Lnc. D/B/A Ev3 Neurovascular | 2021-02-25 | Special | PDF ↗ |
| K202610 | Ventrax Delivery System | Merit Medical Systems, Inc. | 2020-12-14 | Traditional | PDF ↗ |
| K201811 | coraForce and coraFlex Support Catheters | Reflow Medical, Inc. | 2020-10-26 | Traditional | PDF ↗ |
| K193474 | Selectra 3D Outer Guiding Catheters | Biotronik, Inc. | 2020-10-16 | Traditional | PDF ↗ |
| K202252 | ASAHI Corsair Armet 18 Microcatheter (Model: CSAR060-18N), ASAHI Corsair Armet 18 Microcatheter (Model: CSAR090-18N), ASAHI Corsair Armet 18 Microcatheter (Model: CSAR110-18N), ASAHI Corsair Armet 18 Microcatheter (Model: CSAR135-18N), | Asahi Intecc Co., Ltd. | 2020-09-08 | Special | PDF ↗ |
| K200324 | NHancer Rx | Imds Operations B.V. | 2020-08-06 | Traditional | PDF ↗ |
| K192712 | Attain Select II + SureValve delivery catheter system, Attain Command + SureValve Left Heart Delivery System, Attain Comman + SureValve Guide Catheters for Left Heart Delivery, C315 Delivery Catheter | Medtronic, Inc. | 2020-08-03 | Traditional | PDF ↗ |
| K193607 | BOBBY Balloon Guide Catheter | MicroVention, Inc. | 2020-07-21 | Traditional | PDF ↗ |
| K193119 | Twin-Pass Dual Access Catheter | Vascular Solutions, LLC | 2020-06-29 | Traditional | PDF ↗ |
| K201271 | Benchmark BMX96 Access System | Penumbra, Inc. | 2020-06-11 | Special | PDF ↗ |
| K200721 | Agilis HisPro Steerable Catheter With Electrodes | Abbott (St. Jude Medical) | 2020-06-03 | Traditional | PDF ↗ |
| K200317 | Support Catheter | Qxmedical, LLC | 2020-05-14 | Traditional | PDF ↗ |
| K193420 | XO Cross Support Catheter | Transit Scientific | 2020-05-06 | Traditional | PDF ↗ |
| K192558 | Q3 Distal Access Catheter, Q4 Distal Access Catheter, Q5 Distal Access Catheter, Q6Distal Access Catheter | Mivi Neurovascular | 2020-04-06 | Traditional | PDF ↗ |
| K193322 | NovaCross CTO Microcatheter | Nitiloop , Ltd. | 2020-04-02 | Traditional | PDF ↗ |
| K200094 | speX LP Support Catheter | Reflow Medical | 2020-03-18 | Special | PDF ↗ |
| K193596 | Wingman 14, Wingman 14C, Wingman 18, Wingman 35 | Reflow Medical | 2020-02-20 | Traditional | PDF ↗ |
| K193012 | speX Support Catheter | Reflow Medical | 2020-02-19 | Traditional | PDF ↗ |
| K191229 | TrapIt | Imds Operations B.V. | 2020-01-21 | Traditional | PDF ↗ |
| K191717 | Route 92 Medical Sheath System | Route 92 Medical, Inc. | 2020-01-13 | Traditional | PDF ↗ |
| K192774 | BioCardia 8F Morph DNA Deflectable Guide Catheter | Biocardia | 2020-01-07 | Special | PDF ↗ |
| K192135 | VIA Microcatheter (size 17), VIA Microcatheter (size 21), VIA Microcatheter (size 27), VIA Microcatheter (size 33) | MicroVention, Inc. | 2019-12-24 | Traditional | PDF ↗ |
| K191551 | RIST Cath Radial Access Long Sheath | Rist Neurovascular, Inc. | 2019-12-23 | Traditional | PDF ↗ |
| K190833 | AXS Vecta Aspiration Catheter | Stryker Neurovascular | 2019-12-15 | Traditional | PDF ↗ |
| K191163 | Lumax Guiding Catheter | Cook Incorporated | 2019-12-12 | Traditional | PDF ↗ |
| K193034 | AXS Infinity LS Plus Long Sheath | Stryker Neurovascular | 2019-11-29 | Special | PDF ↗ |
| K192782 | ASAHI CROSSWALK Peripheral Support Catheter | Asahi Intecc Co., Ltd. | 2019-11-29 | Traditional | PDF ↗ |
| K192996 | Selectra Catheters, Selectra Accessory Kit, Selectra Slitter Tool | Biotronik, Inc. | 2019-11-21 | Special | PDF ↗ |
| K192625 | PG Pro Microcatheter | MicroVention, Inc. A TERUMO Group Company | 2019-11-21 | Traditional | PDF ↗ |
| K191237 | CERENOVUS Large Bore Catheter | Codman & Shurtleff, Inc. | 2019-11-08 | Traditional | PDF ↗ |
| K192525 | 087 Balloon Guide Catheter System | Q'Apel Medical, LLC | 2019-10-31 | Traditional | PDF ↗ |
| K192296 | Medtronic 6F Taiga Guiding Catheter | Medtronic Vascular | 2019-09-20 | Special | PDF ↗ |
| K191664 | SelectFlex 072 Neurovascular Access System | Q'Apel Medical | 2019-08-30 | Special | PDF ↗ |
| K191560 | Turnpike Catheter; Turnpike Spiral Catheter; Turnpike Gold Catheter; Turnpike LP Catheter | Vascular Solutions, LLC | 2019-08-09 | Traditional | PDF ↗ |
| K183305 | Crossing Support Catheter | Tractus Vascular, LLC | 2019-08-05 | Traditional | PDF ↗ |
| K182487 | CerusEndo Microcatheter | Cerus Endovascular, Inc. | 2019-07-20 | Traditional | PDF ↗ |
| K190749 | 087 Balloon Guide Catheter System | Q'Apel | 2019-07-15 | Traditional | PDF ↗ |
| K182829 | Scepter Mini Occlusion Balloon Catheter | MicroVention, Inc. | 2019-07-10 | Traditional | PDF ↗ |
| K190475 | Delivery Catheter SSPC1, Delivery Catheter SSPC2, Delivery Catheter SSPC3, Delivery Catheter SSPC4 | Centerpoint Systems | 2019-06-28 | Traditional | PDF ↗ |
| K182844 | ASAHI SASUKE | Asahi Intecc Co., Ltd. | 2019-06-22 | Traditional | PDF ↗ |
| K182937 | Upstream GoBack Crossing Catheter | Upstream Peripheral Technologies, Ltd. | 2019-05-23 | Traditional | PDF ↗ |
| K182602 | SOFIA EX Intracranial Support Catheter | MicroVention, Inc. | 2019-05-15 | Traditional | PDF ↗ |
| K190393 | Wingman 14C Crossing Catheter | Reflow Medical, Inc. | 2019-05-09 | Special | PDF ↗ |
| K190581 | Amplatzer Trevisio Intravascular Delivery System | ABBOTT MEDICAL | 2019-04-05 | Special | PDF ↗ |
| K183353 | Telescope Guide Extension Catheter | Medtronic, Inc. | 2019-03-22 | Traditional | PDF ↗ |
| K182918 | Ballast 088 Long Sheath | Balt USA, LLC | 2019-03-21 | Traditional | PDF ↗ |
| K190431 | Route 92 Medical Delivery Catheter | Route 92 Medical, Inc. | 2019-03-21 | Special | PDF ↗ |
| K190401 | MAMBA and MAMBA Flex Microcatheters | Boston Scientific Corporation | 2019-03-15 | Special | PDF ↗ |
| K183493 | SelectSite C304-HIS Deflectable Catheter System | Medtronic, Inc. | 2019-03-15 | Traditional | PDF ↗ |
| K183463 | AXS Catalyst Distal Access Catheter 068 x 115cm, AXS Catalyst Distal Access Catheter 068 x 125cm, AXS Catalyst Distal Access Catheter 068 x 132cm | Stryker | 2019-03-13 | Traditional | PDF ↗ |
| K182570 | Venture 0.014 Catheter | Vascular Solutions, LLC | 2019-03-13 | Traditional | PDF ↗ |
| K183000 | ViperCath XC Peripheral Exchange Catheter | Cardiovascular Systems, Inc. | 2018-12-29 | Traditional | PDF ↗ |
| K182420 | ASAHI Corsair Pro XS | Asahi Intecc Co., Ltd. | 2018-12-20 | Traditional | PDF ↗ |
| K180797 | Xcess Guiding Catheter | Curatia Medical Co. | 2018-12-14 | Traditional | PDF ↗ |
| K183265 | Selectra Catheters, Selectra Accessory Kit | Biotronik, Inc. | 2018-12-13 | Special | PDF ↗ |
| K182512 | Route 92 Medical Delivery Catheter | Route 92 Medical, Inc. | 2018-12-10 | Traditional | PDF ↗ |
| K180889 | Tractus Crossing Support Catheter | Tractus Vascular, LLC | 2018-12-07 | Traditional | PDF ↗ |
| K182097 | React 71 Catheter | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2018-11-14 | Traditional | PDF ↗ |
| K182360 | Teleport Microcatheter | Orbusneich Medical Trading, Inc. | 2018-11-09 | Traditional | PDF ↗ |
| K180919 | GORE Tri-Lumen Catheter | W. L. Gore and Associates, Inc. | 2018-10-05 | Traditional | PDF ↗ |
| K181563 | The ARTERIAL WAND Safety Introducer with Arterial Catheter made of ChronoFlex C with BioGUARD Technology | Access Scientific, LLC | 2018-09-26 | Traditional | PDF ↗ |
| K181000 | SelectFlex 072 Neurovascular Access System | Q'Apel | 2018-09-13 | Traditional | PDF ↗ |
| K180169 | EagleRay Long Sheath, 0.088 ID, 80cm, 90cm, 100cm and 110cm Lengths, EagleRay Access Catheter, 0.071 ID, 137cm Length, EagleRay Access Catheter, 0.055 ID, 137cm Length, EagleRay Access Catheter, 0.045 ID, 144cm Length, EagleRay Access Catheter, 0.035 ID, 158cm Length | Imperative Care, Inc. | 2018-08-08 | Traditional | PDF ↗ |
| K180864 | WATCHMAN TruSeal Access System | Boston Scientific | 2018-07-20 | Traditional | PDF ↗ |
| K180715 | React 68 Catheter | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2018-07-04 | Traditional | PDF ↗ |
| K180959 | Phenom 27 Catheter | Cathera, Inc. | 2018-06-11 | Special | PDF ↗ |
| K180201 | Route 92 Medical Access System | Route 92 Medical, Inc. | 2018-05-23 | Traditional | PDF ↗ |
| K180986 | XableCath Support Catheter Product Family | Xablecath, Inc. | 2018-05-15 | Special | PDF ↗ |
| K173661 | Wingman 35 Crossing Catheter | Reflow Medical, Inc. | 2018-04-18 | Traditional | PDF ↗ |
| K172014 | Wedge Microcatheter | MicroVention, Inc. | 2018-04-05 | Traditional | PDF ↗ |
| K180088 | TrapLiner catheter | Vascular Solutions, Inc. | 2018-04-04 | Special | PDF ↗ |
| K173548 | Merit Pursue Microcatheter | Merit Medical Systems, Inc. | 2018-03-30 | Traditional | PDF ↗ |
| K173799 | NaviCross 0.018 | Terumo Corporation | 2018-03-29 | Traditional | PDF ↗ |
| K173709 | Zenith Support, 95 cm, Zenith Support, 105 cm, Zenith Support, 115 cm | Inneuroco, Inc. | 2018-01-26 | Special | PDF ↗ |
| K173560 | Microcatheter | Surmodics,Inc. | 2018-01-12 | Traditional | PDF ↗ |
| K171819 | Attain Assist CS Access Catheter | Creganna Medical Also Doing Business AS Ceganna Tactx Medica | 2018-01-04 | Traditional | PDF ↗ |
| K173662 | speX Support Catheter | Reflow Medical, Inc. | 2017-12-20 | Special | PDF ↗ |
| K172468 | 091 Long Sheath, 70 cm, 091 Long Sheath, 80 cm, 091 Long Sheath, 90 cm | Inneuroco, Inc. | 2017-12-06 | Traditional | PDF ↗ |
| K170914 | TXM Support Catheter | Texasmedical Technologies, Inc. | 2017-11-21 | Traditional | PDF ↗ |
| K170664 | Odyssey Micro Catheter | Heraeus Medical Components, LLC | 2017-11-09 | Traditional | PDF ↗ |
| K172090 | GuideLiner V3 Catheter | Vascular Solutions, Inc. | 2017-10-20 | Traditional | PDF ↗ |
| K171672 | 065 Zenith, 074 Zenith | Inneuroco, Inc. | 2017-10-19 | Traditional | PDF ↗ |
| K172297 | NovaCross Microcatheter | Nitiloop , Ltd. | 2017-10-18 | Special | PDF ↗ |
| K171176 | M-CATH Microcatheter | Acrostak (Schweiz) AG | 2017-09-15 | Traditional | PDF ↗ |
| K170041 | XableCath Support Catheter | Xablecath, Inc. | 2017-09-07 | Traditional | PDF ↗ |
| K171452 | MAMBA and MAMBA FLEX Microcatheters | Boston Scientific Corporation | 2017-08-21 | Traditional | PDF ↗ |
| K163259 | AXS Offset Delivery Assist Catheter | Stryker Neurovascular | 2017-07-28 | Traditional | PDF ↗ |
| K171913 | Rubicon 14, 18 and 35 Support Catheters | Boston Scientific Corporation | 2017-07-25 | Special | PDF ↗ |
| K171653 | YOGA Microcatheter, 0.032, 150cm, Back Up and Extra Back Up | Codman & Shurtleff, Inc. | 2017-07-03 | Special | PDF ↗ |
| K171612 | ACUITY Pro Lead Delivery System | Boston Scientific Corporation | 2017-06-30 | Special | PDF ↗ |
| K171146 | Arrow Seldinger Arterial Catheterization Device 18 ga., Arrow Seldinger Arterial Catheterization Device 20 ga., Arrow Seldinger Arterial Catheterization Device 22 ga., Arrow Seldinger Arterial Catheterization Device 24 ga. | Arrow International, Inc. (Subsidiary of Telelflex Inc.) | 2017-06-23 | Special | PDF ↗ |
| K170996 | Wingman 14C Crossing Catheter | Reflow Medical, Inc. | 2017-06-09 | Special | PDF ↗ |
| K171335 | Venture 038 catheter | Vascular Solutions, Inc. | 2017-06-07 | Special | PDF ↗ |
| K171268 | Reverse 021 Micro Catheter, Reverse 027 Micro Catheter | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2017-05-31 | Traditional | PDF ↗ |
| K163233 | MIVI 6F 25cm Mi-EXT Extension Catheter, MIVI 5F 25cm Mi-EXT Extension Catheter, MIVI 4F 30cm Mi-EXT Extension Catheter, MIVI 3F 43cm Mi-EXT Extension Catheter | Mivi Neuroscience, Inc. | 2017-04-06 | Traditional | PDF ↗ |
| K163314 | Guidezilla II Guide Extension Catheter; Guidezilla II LONG Guide Extension Catheter | Boston Scientific Corporation | 2017-03-23 | Traditional | PDF ↗ |
| K170403 | CenterCross Ultra LV Catheter | Roxwood Medical, Inc. | 2017-03-07 | Special | PDF ↗ |
| K162565 | VIA 17 Microcatheter | Sequent Medical, Inc. | 2017-02-18 | Traditional | PDF ↗ |
| K161901 | TrapLiner catheter | Vascular Solutions, Inc. | 2017-02-03 | Traditional | PDF ↗ |
Product code DQY · Class II · Cardiovascular. Data: openFDA.