DQY · Class II · 21 CFR 870.1250

FDA Product Code DQY: Catheter, Percutaneous

Percutaneous catheters are foundational tools in interventional cardiology and vascular medicine. FDA product code DQY covers catheters designed for percutaneous access to the vascular system.

These devices enable clinicians to navigate blood vessels to deliver therapies, measure pressures, or access cardiac structures without open surgery. They are used in angioplasty, electrophysiology, structural heart procedures, and hemodynamic monitoring.

DQY devices are Class II medical devices, regulated under 21 CFR 870.1250 and reviewed by the FDA Cardiovascular panel.

Leading manufacturers include Medtronic Vascular, Cordis Corp. and C.R. Bard, Inc..

889
Total
889
Cleared
104d
Avg days
1979
Since
889 devices
25–48 of 889
Cleared Jan 07, 2025
COREPASS Modular Microcatheter (FLEX)
K242588
OrbusNeich Medical (Shenzhen) Co., Ltd.
Cardiovascular · 130d
Cleared Dec 31, 2024
MitraClip™ G5 Steerable Guide Catheter (SGC0801)
K243224
Abbott Medical
Cardiovascular · 85d
Cleared Dec 20, 2024
SENDERO MAX Delivery Catheter
K242644
Okami Medical, Inc.
Cardiovascular · 108d
Cleared Dec 19, 2024
Shadow Catheter
K240885
Simpson Interventions, Inc.
Cardiovascular · 262d
Cleared Dec 04, 2024
SSPC NXT Delivery Catheter
K243180
CenterPoint Systems, LLC
Cardiovascular · 65d
Cleared Sep 30, 2024
CrossFAST™ Integrated Microcatheter Guide Extension System (CFM55)
K242276
Vantis Vascular, Inc.
Cardiovascular · 60d
Cleared Sep 12, 2024
Selectra 3D Lead Delivery System (443624-443629, 451789-451791)
K240787
Biotronik, Inc.
Cardiovascular · 174d
Cleared Sep 03, 2024
ShapeIT (SI014135)
K241611
Imds Operations B.V.
Cardiovascular · 90d
Cleared Aug 26, 2024
TriClip Steerable Guide Catheter
K241538
Abbott Medical
Cardiovascular · 88d
Cleared Jun 28, 2024
Cordis BRITECROSS Support Catheter
K233637
Cordis US Corp
Cardiovascular · 228d
Cleared Jun 25, 2024
ASAHI Veloute
K241158
Asahi Intecc Co., Ltd.
Cardiovascular · 60d
Cleared May 28, 2024
React 71 Catheter
K241177
Micro Therapeutics Lnc. D/B/A Ev3 Neurovascular
Neurology · 29d
Cleared Mar 15, 2024
APRO 55 Catheter
K234115
Alembic, LLC
Neurology · 79d
Cleared Mar 08, 2024
SENDERO Microcatheter
K240384
Okami Medical, Inc.
Cardiovascular · 29d
Cleared Feb 08, 2024
SINC Support Catheter
K233350
Reflow Medical, Inc.
Cardiovascular · 132d
Cleared Feb 01, 2024
WATCHMAN TruSteer Access System (M635TU90050)
K240018
Boston Scientific Corporation
Cardiovascular · 30d
Cleared Jan 07, 2024
Teleport XT Microcatheter
K231608
OrbusNeich Medical (Shenzhen) Co., Ltd.
Cardiovascular · 219d
Cleared Dec 27, 2023
TriSalus TriGuideTM Guiding Catheter
K233858
Trisalus Life Sciences
Cardiovascular · 22d
Cleared Nov 17, 2023
SENDERO Microcatheter
K231600
Okami Medical, Inc.
Cardiovascular · 169d
Cleared Oct 31, 2023
091 Balloon Guide Catheter
K231629
Eosolutions, Corp.
Neurology · 148d
Cleared Oct 13, 2023
Paragon 8F Balloon Guide Catheter
K232437
Wallaby Medical
Neurology · 60d
Cleared Sep 29, 2023
Microcatheter
K232647
Surmodics,Inc.
Cardiovascular · 29d
Cleared Sep 29, 2023
Amulet™ Steerable Delivery Sheath
K232690
Abbott Medical
Cardiovascular · 28d
Cleared Aug 30, 2023
Ventrax™ Delivery System (VTR851)
K231246
Merit Medical Systems, Inc.
Cardiovascular · 121d