ClearanceBrief
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)
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Top companies in DQY

Decided510(k)Device and applicantCode
Sep 18, 2026K262817CrossFAST Integrated Microcatheter Advanced Delivery System
Vantis Vascular, Inc.
DQY
Aug 14, 2026K260559NHanceIT
IMDS Operation B.V., NL
DQY
Aug 12, 2026K262392APRO 35 Swift Catheter
Alembic, LLC
DQY
Jul 29, 2026K262240SSPC NXT Delivery Catheter
CenterPoint Systems, LLC
DQY
Jul 29, 2026K261766CPS Locator 3D Plus Delivery Catheter
CenterPoint Systems, LLC
DQY
Jul 2, 2026K261825Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP Catheter
Abbott
DQY
Jun 17, 2026K261631Amplatzer TorqVue Exchange System
Abbott Medical
DQY
Jun 5, 2026K260289Perfect-O Ostial Positioning Catheter
Balosmark, Inc.
DQY
Apr 24, 2026K260993Amplatzer TorqVue Delivery System
Abbott
DQY
Apr 10, 2026K253361Teleport Glide Microcatheter
OrbusNeich Medical (Shenzhen) Co., Ltd., CN
DQY
Mar 13, 2026K260499Amplatzer™ Trevisio™ Intravascular Delivery System; 9-ATV06F45/609-ATV07F45/609-ATV07F45/809-ATV08F45/609-ATV08F45/809-A
ABBOTT MEDICAL
DQY
Dec 19, 2025K253409C320LBB Delivery System (C320LBBS45), C320LBB Delivery System (C320LBBS48), C320LBB Delivery System (C320LBBL45), C320LB
Medtronic, Inc.
DQY
Dec 17, 2025K252417Amplatzer Piccolo™ Delivery System (9-PDS-04F-045)
ABBOTT MEDICAL
DQY
Oct 29, 2025K252390Telescope Guide Extension Catheter
Medtronic, Ireland, IE
DQY
Aug 22, 2025K251277CoraForce Microcatheter, CoraFlex Microcatheter
Reflow Medical, Inc.
DQY
Aug 22, 2025K250147CPS Locator 3D Delivery Catheter
Centerpoint Systems
DQY
Jun 29, 2025K250972Primum Hydrophilic Guiding Catheter
Pendracare, NL
DQY
Jun 27, 2025K250828CPS Locator 3D Plus Delivery Catheter
CenterPoint Systems, LLC
DQY
Jun 25, 2025K243184SAT CenterFlow Molding Balloon Catheter (IN20-00313)
Strait Access Technologies Holdings, ZA
DQY
Jun 18, 2025K250492FlexiGo 3D Delivery Catheter
CenterPoint Systems, LLC
DQY
Jun 17, 2025K250219Dorado™ PTA Balloon Dilatation Catheter
Bard Peripheral Vascular, Inc.
DQY
Jun 2, 2025K250410GORE® Tri-Lobe Balloon Catheter
W. L. Gore & Associates, Inc.
DQY
May 2, 2025K243757Shockwave CS Guide Catheter
Shockwave Medical, Inc.
DQY
May 1, 2025K251014APRO 45 Catheter
Alembic, LLC
DQY
Apr 29, 2025K250962APRO 55 Intermediate Catheter
Alembic, LLC
DQY
Apr 25, 2025K250426Amulet™ Steerable Delivery Sheath
ABBOTT MEDICAL
DQY
Apr 17, 2025K242337FlowGuide (FG60F); GuidionShort (GS60F)
Imds Operations B.V., NL
DQY
Apr 4, 2025K243691LiquID .051 LP Guide Catheter Extension
Seigla Medical, Inc.
DQY
Mar 27, 2025K250558SelectSite C304 Deflectable Catheter System (C304); C315 Delivery System (C315)
Medtronic, Inc.
DQY
Feb 28, 2025K243436Seclusion Catheter
Basis Medical
DQY
Jan 15, 2025K242873Ventrax™ Delivery System
Merit Medical Systems, Inc.
DQY
Jan 7, 2025K242588COREPASS Modular Microcatheter (FLEX); COREPASS Modular Microcatheter (CONTROL)
OrbusNeich Medical (Shenzhen) Co., Ltd., CN
DQY
Dec 31, 2024K243224MitraClip™ G5 Steerable Guide Catheter (SGC0801); TriClip™ G5 Steerable Guide Catheter (TSGC0801)
ABBOTT MEDICAL
DQY
Dec 20, 2024K242644SENDERO MAX Delivery Catheter
Okami Medical, Inc.
DQY
Dec 19, 2024K240885Shadow Catheter
Simpson Interventions, Inc.
DQY
Dec 4, 2024K243180SSPC NXT Delivery Catheter
CenterPoint Systems, LLC
DQY
Sep 30, 2024K242276CrossFAST™ Integrated Microcatheter Guide Extension System (CFM55)
Vantis Vascular, Inc.
DQY
Sep 12, 2024K240787Selectra 3D Lead Delivery System (443624-443629, 451789-451791); Selectra Slitter Tool (383119); Selectra Accessory Kit
Biotronik, Inc.
DQY
Sep 3, 2024K241611ShapeIT (SI014135)
Imds Operations B.V., NL
DQY
Aug 26, 2024K241538TriClip Steerable Guide Catheter
ABBOTT MEDICAL
DQY
Jun 28, 2024K233637Cordis BRITECROSS Support Catheter
Cordis US Corp
DQY
Jun 25, 2024K241158ASAHI Veloute; ASAHI Veloute C3; ASAHI Tellus; ASAHI Tellus C3
Asahi Intecc Co., Ltd., JP
DQY
May 28, 2024K241177React 71 Catheter
Micro Therapeutics Lnc. D/B/A Ev3 Neurovascular
DQY
Mar 15, 2024K234115APRO 55 Catheter
Alembic, LLC
DQY
Mar 8, 2024K240384SENDERO Microcatheter
Okami Medical, Inc.
DQY
Feb 8, 2024K233350SINC Support Catheter
Reflow Medical, Inc.
DQY
Feb 1, 2024K240018WATCHMAN TruSteer Access System (M635TU90050)
Boston Scientific Corporation
DQY
Jan 7, 2024K231608Teleport XT Microcatheter
OrbusNeich Medical (Shenzhen) Co., Ltd., CN
DQY
Dec 27, 2023K233858TriSalus TriGuideTM Guiding Catheter
Trisalus Life Sciences
DQY
Nov 17, 2023K231600SENDERO Microcatheter
Okami Medical, Inc.
DQY

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