Panels › Cardiovascular › Product code DQY · Class 2
Catheter, Percutaneous
Regulation 870.1250
13510(k)s in 12 months (896 all time)
2recalls in 12 months (620 all time)
583recalls that name a 510(k)
Top companies in DQY
| Company | 510(k)s | Recalls |
|---|---|---|
| Medtronic Vascular | 31 | 198 |
| Medtronic | 15 | 148 |
| Boston Scientific | 30 | 59 |
| ARROW INTERNATIONAL, LLC | 0 | 41 |
| Stryker Neurovascular | 6 | 30 |
| Cook Incorporated | 22 | 13 |
| Vascular Solutions, Inc. | 27 | 6 |
| Codman & Shurtleff, Inc. | 8 | 24 |
| Bard Peripheral Vascular, Inc. | 5 | 23 |
| Cordis Corp. | 22 | 4 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 18, 2026 | K262817 | CrossFAST Integrated Microcatheter Advanced Delivery System Vantis Vascular, Inc. | DQY |
| Aug 14, 2026 | K260559 | NHanceIT IMDS Operation B.V., NL | DQY |
| Aug 12, 2026 | K262392 | APRO 35 Swift Catheter Alembic, LLC | DQY |
| Jul 29, 2026 | K262240 | SSPC NXT Delivery Catheter CenterPoint Systems, LLC | DQY |
| Jul 29, 2026 | K261766 | CPS Locator 3D Plus Delivery Catheter CenterPoint Systems, LLC | DQY |
| Jul 2, 2026 | K261825 | Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP Catheter Abbott | DQY |
| Jun 17, 2026 | K261631 | Amplatzer TorqVue Exchange System Abbott Medical | DQY |
| Jun 5, 2026 | K260289 | Perfect-O Ostial Positioning Catheter Balosmark, Inc. | DQY |
| Apr 24, 2026 | K260993 | Amplatzer TorqVue Delivery System Abbott | DQY |
| Apr 10, 2026 | K253361 | Teleport Glide Microcatheter OrbusNeich Medical (Shenzhen) Co., Ltd., CN | DQY |
| Mar 13, 2026 | K260499 | Amplatzer Trevisio Intravascular Delivery System; 9-ATV06F45/609-ATV07F45/609-ATV07F45/809-ATV08F45/609-ATV08F45/809-A ABBOTT MEDICAL | DQY |
| Dec 19, 2025 | K253409 | C320LBB Delivery System (C320LBBS45), C320LBB Delivery System (C320LBBS48), C320LBB Delivery System (C320LBBL45), C320LB Medtronic, Inc. | DQY |
| Dec 17, 2025 | K252417 | Amplatzer Piccolo Delivery System (9-PDS-04F-045) ABBOTT MEDICAL | DQY |
| Oct 29, 2025 | K252390 | Telescope Guide Extension Catheter Medtronic, Ireland, IE | DQY |
| Aug 22, 2025 | K251277 | CoraForce Microcatheter, CoraFlex Microcatheter Reflow Medical, Inc. | DQY |
| Aug 22, 2025 | K250147 | CPS Locator 3D Delivery Catheter Centerpoint Systems | DQY |
| Jun 29, 2025 | K250972 | Primum Hydrophilic Guiding Catheter Pendracare, NL | DQY |
| Jun 27, 2025 | K250828 | CPS Locator 3D Plus Delivery Catheter CenterPoint Systems, LLC | DQY |
| Jun 25, 2025 | K243184 | SAT CenterFlow Molding Balloon Catheter (IN20-00313) Strait Access Technologies Holdings, ZA | DQY |
| Jun 18, 2025 | K250492 | FlexiGo 3D Delivery Catheter CenterPoint Systems, LLC | DQY |
| Jun 17, 2025 | K250219 | Dorado PTA Balloon Dilatation Catheter Bard Peripheral Vascular, Inc. | DQY |
| Jun 2, 2025 | K250410 | GORE® Tri-Lobe Balloon Catheter W. L. Gore & Associates, Inc. | DQY |
| May 2, 2025 | K243757 | Shockwave CS Guide Catheter Shockwave Medical, Inc. | DQY |
| May 1, 2025 | K251014 | APRO 45 Catheter Alembic, LLC | DQY |
| Apr 29, 2025 | K250962 | APRO 55 Intermediate Catheter Alembic, LLC | DQY |
| Apr 25, 2025 | K250426 | Amulet Steerable Delivery Sheath ABBOTT MEDICAL | DQY |
| Apr 17, 2025 | K242337 | FlowGuide (FG60F); GuidionShort (GS60F) Imds Operations B.V., NL | DQY |
| Apr 4, 2025 | K243691 | LiquID .051 LP Guide Catheter Extension Seigla Medical, Inc. | DQY |
| Mar 27, 2025 | K250558 | SelectSite C304 Deflectable Catheter System (C304); C315 Delivery System (C315) Medtronic, Inc. | DQY |
| Feb 28, 2025 | K243436 | Seclusion Catheter Basis Medical | DQY |
| Jan 15, 2025 | K242873 | Ventrax Delivery System Merit Medical Systems, Inc. | DQY |
| Jan 7, 2025 | K242588 | COREPASS Modular Microcatheter (FLEX); COREPASS Modular Microcatheter (CONTROL) OrbusNeich Medical (Shenzhen) Co., Ltd., CN | DQY |
| Dec 31, 2024 | K243224 | MitraClip G5 Steerable Guide Catheter (SGC0801); TriClip G5 Steerable Guide Catheter (TSGC0801) ABBOTT MEDICAL | DQY |
| Dec 20, 2024 | K242644 | SENDERO MAX Delivery Catheter Okami Medical, Inc. | DQY |
| Dec 19, 2024 | K240885 | Shadow Catheter Simpson Interventions, Inc. | DQY |
| Dec 4, 2024 | K243180 | SSPC NXT Delivery Catheter CenterPoint Systems, LLC | DQY |
| Sep 30, 2024 | K242276 | CrossFAST Integrated Microcatheter Guide Extension System (CFM55) Vantis Vascular, Inc. | DQY |
| Sep 12, 2024 | K240787 | Selectra 3D Lead Delivery System (443624-443629, 451789-451791); Selectra Slitter Tool (383119); Selectra Accessory Kit Biotronik, Inc. | DQY |
| Sep 3, 2024 | K241611 | ShapeIT (SI014135) Imds Operations B.V., NL | DQY |
| Aug 26, 2024 | K241538 | TriClip Steerable Guide Catheter ABBOTT MEDICAL | DQY |
| Jun 28, 2024 | K233637 | Cordis BRITECROSS Support Catheter Cordis US Corp | DQY |
| Jun 25, 2024 | K241158 | ASAHI Veloute; ASAHI Veloute C3; ASAHI Tellus; ASAHI Tellus C3 Asahi Intecc Co., Ltd., JP | DQY |
| May 28, 2024 | K241177 | React 71 Catheter Micro Therapeutics Lnc. D/B/A Ev3 Neurovascular | DQY |
| Mar 15, 2024 | K234115 | APRO 55 Catheter Alembic, LLC | DQY |
| Mar 8, 2024 | K240384 | SENDERO Microcatheter Okami Medical, Inc. | DQY |
| Feb 8, 2024 | K233350 | SINC Support Catheter Reflow Medical, Inc. | DQY |
| Feb 1, 2024 | K240018 | WATCHMAN TruSteer Access System (M635TU90050) Boston Scientific Corporation | DQY |
| Jan 7, 2024 | K231608 | Teleport XT Microcatheter OrbusNeich Medical (Shenzhen) Co., Ltd., CN | DQY |
| Dec 27, 2023 | K233858 | TriSalus TriGuideTM Guiding Catheter Trisalus Life Sciences | DQY |
| Nov 17, 2023 | K231600 | SENDERO Microcatheter Okami Medical, Inc. | DQY |
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