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, Biotronik, Inc. and Vascular Solutions, Inc..

895
Total
895
Cleared
104d
Avg days
1979
Since
895 devices
169–192 of 895
Cleared Apr 18, 2018
Wingman 35 Crossing Catheter
K173661
Reflow Medical, Inc.
Cardiovascular · 140d
Cleared Apr 05, 2018
Wedge Microcatheter
K172014
MicroVention, Inc.
Cardiovascular · 276d
Cleared Apr 04, 2018
TrapLiner catheter
K180088
Vascular Solutions, Inc.
Cardiovascular · 82d
Cleared Mar 30, 2018
Merit Pursue Microcatheter
K173548
Merit Medical Systems, Inc.
Cardiovascular · 134d
Cleared Mar 29, 2018
NaviCross 0.018
K173799
Terumo Corporation
Cardiovascular · 105d
Cleared Jan 26, 2018
Zenith Support, 95 cm, Zenith Support, 105 cm, Zenith Support, 115 cm
K173709
Inneuroco, Inc.
Cardiovascular · 53d
Cleared Jan 12, 2018
Microcatheter
K173560
Surmodics,Inc.
Cardiovascular · 56d
Cleared Jan 04, 2018
Attain Assist CS Access Catheter
K171819
Creganna Medical Also Doing Business AS Ceganna Tactx Medica
Cardiovascular · 199d
Cleared Dec 20, 2017
speX Support Catheter
K173662
Reflow Medical, Inc.
Cardiovascular · 21d
Cleared Dec 06, 2017
091 Long Sheath, 70 cm, 091 Long Sheath, 80 cm, 091 Long Sheath, 90 cm
K172468
Inneuroco, Inc.
Cardiovascular · 113d
Cleared Nov 21, 2017
TXM Support Catheter
K170914
Texasmedical Technologies, Inc.
Cardiovascular · 238d
Cleared Nov 09, 2017
Odyssey Micro Catheter
K170664
Heraeus Medical Components, LLC
Cardiovascular · 248d
Cleared Oct 20, 2017
GuideLiner V3 Catheter
K172090
Vascular Solutions, Inc.
Cardiovascular · 101d
Cleared Oct 19, 2017
065 Zenith, 074 Zenith
K171672
Inneuroco, Inc.
Cardiovascular · 135d
Cleared Oct 18, 2017
NovaCross Microcatheter
K172297
Nitiloop , Ltd.
Cardiovascular · 79d
Cleared Sep 15, 2017
M-CATH Microcatheter
K171176
Acrostak (Schweiz) AG
Cardiovascular · 147d
Cleared Sep 07, 2017
XableCath Support Catheter
K170041
Xablecath, Inc.
Cardiovascular · 245d
Cleared Aug 21, 2017
MAMBA and MAMBA FLEX Microcatheters
K171452
Boston Scientific Corporation
Cardiovascular · 96d
Cleared Jul 28, 2017
AXS Offset Delivery Assist Catheter
K163259
Stryker Neurovascular
Cardiovascular · 249d
Cleared Jul 25, 2017
Rubicon 14, 18 and 35 Support Catheters
K171913
Boston Scientific Corporation
Cardiovascular · 29d
Cleared Jul 03, 2017
YOGA Microcatheter, 0.032, 150cm, Back Up and Extra Back Up
K171653
Codman & Shurtleff, Inc.
Cardiovascular · 28d
Cleared Jun 30, 2017
ACUITY Pro Lead Delivery System
K171612
Boston Scientific Corporation
Cardiovascular · 29d
Cleared Jun 23, 2017
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.
K171146
Arrow International, Inc. (Subsidiary of Telelflex Inc.)
Cardiovascular · 65d
Cleared Jun 09, 2017
Wingman 14C Crossing Catheter
K170996
Reflow Medical, Inc.
Cardiovascular · 67d