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)
Get daily alerts for DQYSample briefCSV

Top companies in DQY

DateFirm and productCodeLinked 510(k)
Aug 7, 2026MICROVENTION INC.
BOBBY Balloon Guide Catheter REF: BOB-895-CN BOB-895-EMEA BOB-895-EMEA-AL BOB-895-US MV-BGA01095 For use in facilitating the insertion and guidance of an intravascular catheter into a selected blood
Open, Classified
DQYK193607
Jun 13, 2026ARROW INTERNATIONAL, LLC
Description/REF: ARTERIAL LINE KIT: SL 20 GA X 5 IN/ASK-04510-MM6 RA CATH KIT: 20 GA X 1-3/4IN/NA-04020-X1ASP ACCESS TRAY/ASK-04001-MS RA CATH KIT: 20 GA X 8 CM/ASK-00820-UM1 VESSEL CATH KIT: 20GA X 5
Open, Classified
DQYK021120
K171146 +3
Oct 24, 2025BALT USA, LLC
Brand Name: MEGA Ballast Distal Access Platform Product Name: Mega Ballast Model/Catalog Number: MEGABT09180, MEGABT09190, MEGABT091100, MEGABT091110 Software Version: N/A Product Description: The Meg
Open, Classified
DQYK242376
Aug 29, 2025Boston Scientific Corporation
WATCHMAN TruSteer Access System, US, Material Number (UPN) M635TU90050;intended to provide vascular and transseptal access for the family of WATCHMAN FLX LAAC Devices with Delivery Systems.
Open, Classified
DQYK240018
Aug 29, 2025Boston Scientific Corporation
WATCHMAN FXD Curve Access System Dbl, US, Material Number (UPN) M635TU80020; intended to provide vascular and transseptal access for the family of WATCHMAN FLX LAAC Devices with Delivery Systems.
Open, Classified
DQYK212228
Aug 29, 2025Boston Scientific Corporation
WATCHMAN FXD Curve Access System Sgl, US, Material Number (UPN) M635TU80010; intended to provide vascular and transseptal access for the family of WATCHMAN FLX LAAC Devices with Delivery Systems.
Open, Classified
DQYK212228
Aug 29, 2025Boston Scientific Corporation
WATCHMAN TruSeal Access System ANT, US, Material Number (UPN) M635TU70040; intended to provide vascular and transseptal access for all WATCHMAN Left Atrial Appendage Closure Devices with Delivery Syst
Open, Classified
DQYNone listed
Aug 29, 2025Boston Scientific Corporation
WATCHMAN TruSeal Access System DBL, US, Material Number (UPN) M635TU70020; intended to provide vascular and transseptal access for all WATCHMAN Left Atrial Appendage Closure Devices with Delivery Syst
Open, Classified
DQYK180864
Aug 29, 2025Boston Scientific Corporation
WATCHMAN TruSeal Access System SGL, US, Material Number (UPN) M635TU70010; intended to provide vascular and transseptal access for all WATCHMAN Left Atrial Appendage Closure Devices with Delivery Syst
Open, Classified
DQYK180864
Aug 29, 2025Boston Scientific Corporation
WATCHMAN FXD Curve Access Sys Dbl, OUS, Material Number (UPN) M635TS80020; intended to provide vascular and transseptal access for the family of WATCHMAN FLX LAAC Devices with Delivery Systems.
Open, Classified
DQYNone listed
Aug 29, 2025Boston Scientific Corporation
WATCHMAN FXD Curve Access Sys Sgl, OUS, Material Number (UPN) M635TS80010; intended to provide vascular and transseptal access for the family of WATCHMAN FLX LAAC Devices with Delivery Systems.
Open, Classified
DQYK212228
Aug 29, 2025Boston Scientific Corporation
WATCHMAN TruSeal Access System ANT, OUS, Material Number (UPN) M635TS70040; intended to provide vascular and transseptal access for all WATCHMAN Left Atrial Appendage Closure Devices with Delivery Sys
Open, Classified
DQYK180864
Aug 29, 2025Boston Scientific Corporation
WATCHMAN TruSeal Access System DBL, OUS, Material Number (UPN) M635TS70020; intended to provide vascular and transseptal access for all WATCHMAN Left Atrial Appendage Closure Devices with Delivery Sys
Open, Classified
DQYK180864
Aug 29, 2025Boston Scientific Corporation
WATCHMAN TruSeal Access System SGL, OUS, Material Number (UPN) M635TS70010; intended to provide vascular and transseptal access for all WATCHMAN Left Atrial Appendage Closure Devices with Delivery Sys
Open, Classified
DQYK180864
Apr 21, 2025Abbott
Amplatzer TorqVue LP Catheter (TVLPC), Model no. 9-TVLPC4F90/080
Open, Classified
DQYK162228
Apr 21, 2025Abbott
Amplatzer TorqVue LP Delivery System (TVLP), Model nos. 9-TVLP4F90/060 and 9-TVLP4F90/080
Open, Classified
DQYK131063
Mar 13, 2025Cordis US Corp
Vista Brite Tip, Judkins Right 4, REF SM7504, JR3 VBT (Special) 110 cm 6F. Guiding catheter is intended for use for intravascular introduction of interventional/diagnostic devices into the coronary or
Open, Classified
DQYK021593
Jan 17, 2025MICROVENTION INC.
Microvention, Headway" 17 Advanced Straight Microcatheter with Hydrophilic Coating, REF: MC172150SX-CN, Sterile R, Rx Only, Lot# 0000629846
Open, Classified
DQYK101542
May 28, 2024Stryker Neurovascular
DAC 044 115cm, Catalog: 90760
Open, Classified
DQYK133177
May 28, 2024Stryker Neurovascular
FlowGate2 8F x 85cm, Catalog: 90485 FlowGate2 8F x 95cm, Catalog: 90495
Open, Classified
DQYK153729
May 1, 2024Stryker Neurovascular
The Distal Access Catheter is a single-lumen, braided shaft, variable stiffness catheter with radiopaque marker on the distal end and a luer hub on the proximal end. The catheter shaft has a hydrophil
Open, Classified
DQYK133177
Apr 24, 2024ROUTE 92 MEDICAL INC
Route 92 Medical 070 Reperfusion System, REF 1003, Rxonly, SterileEO. Used for introduction of interventional devices into the neurovasculature and aspiration of thrombus in ischemic stroke patients.
Open, Classified
DQYNone listed
Apr 24, 2024ROUTE 92 MEDICAL INC
Route 92 Medical, Tenzing 7 Delivery Catheter, REF 1005, Rx Only, Sterile EO. Used for introduction of interventional devices into the neurovasculature.
Open, Classified
DQYK190431
Jan 2, 2024Merit Medical Systems, Inc.
Merit Pursue Microcatheter, REF: 28HC17130SN, 28HC17150ST/A, 29HC2015045/A, 29HC20150SN/A, 29HC20150ST, CE 2797, STERILEEO, Rx ONLY
Open, Classified
DQYK173548
Oct 3, 2023Boston Scientific Corporation
Guider Softip Guide Catheter 5F 100CM MULTI PURPOSE, Catalog number M003101630, cardiac guide catheter
Open, Classified
DQYNone listed
Oct 3, 2023Boston Scientific Corporation
Guider Softip Guide Catheter 5F PRE-SHAPED 40 100CM, Catalog number M003101620, cardiac guide catheter
Open, Classified
DQYNone listed
Oct 3, 2023Boston Scientific Corporation
Guider Softip Guide Catheter 8F 100CM MULTI PURPOSE, Catalog number M003101480, cardiac guide catheter
Open, Classified
DQYNone listed
Oct 3, 2023Boston Scientific Corporation
Guider Softip Guide Catheter 7F 100CM MULTI PURPOSE, Catalog number M003101470, cardiac guide catheter
Open, Classified
DQYNone listed
Oct 3, 2023Boston Scientific Corporation
Guider Softip Guide Catheter 6F 100CM MULTI PURPOSE, Catalog number M003101460, cardiac guide catheter
Open, Classified
DQYNone listed
Oct 3, 2023Boston Scientific Corporation
Guider Softip Guide Catheter 8F PRE-SHAPED 40 100CM, Catalog number M003101440, cardiac guide catheter
Open, Classified
DQYNone listed
Oct 3, 2023Boston Scientific Corporation
Guider Softip Guide Catheter 7F PRE-SHAPED 40 100CM, Catalog number M003101430, cardiac guide catheter
Open, Classified
DQYNone listed
Oct 3, 2023Boston Scientific Corporation
Guider Softip Guide Catheter 6F PRE-SHAPED 40 100CM, Catalog number M003101420, cardiac guide catheter
Open, Classified
DQYNone listed
Oct 3, 2023Boston Scientific Corporation
Guider Softip Guide Catheter 5F 90CM MULTI PURPOSE, Catalog number M003100630, cardiac guide catheter
Open, Classified
DQYNone listed
Oct 3, 2023Boston Scientific Corporation
Guider Softip Guide Catheter 5F PRE-SHAPED 40 90CM, Catalog number M003100620, cardiac guide catheter
Open, Classified
DQYNone listed
Oct 3, 2023Boston Scientific Corporation
Guider Softip Guide Catheter 8F 90CM MULTI PURPOSE, Catalog number H965100480, cardiac guide catheter
Open, Classified
DQYNone listed
Oct 3, 2023Boston Scientific Corporation
Guider Softip Guide Catheter 7F 90CM MULTI PURPOSE, Catalog number H965100470, cardiac guide catheter
Open, Classified
DQYNone listed
Oct 3, 2023Boston Scientific Corporation
Guider Softip Guide Catheter 6F 90CM MULTI PURPOSE, Catalog number H965100460, cardiac guide catheter
Open, Classified
DQYNone listed
Oct 3, 2023Boston Scientific Corporation
Guider Softip Guide Catheter 8F PRE-SHAPED 40 90CM, Catalog number H965100440, cardiac guide catheter
Open, Classified
DQYNone listed
Oct 3, 2023Boston Scientific Corporation
Guider Softip Guide Catheter 7F PRE-SHAPED 40 90CM, Catalog number H965100430, cardiac guide catheter
Open, Classified
DQYNone listed
Oct 3, 2023Boston Scientific Corporation
Guider Softip Guide Catheter 6F PRE-SHAPED 40 90CM, Catalog number H965100420, cardiac guide catheter
Open, Classified
DQYNone listed
Jul 11, 2023Abbott
Abbott Amplatzer Steerable Delivery Sheath (ASDS), REF ASDS-14F-075, is a percutaneous catheter (cardiac).
Open, Classified
DQYK220340
Mar 13, 2023Scientia Vascular, Inc.
Plato 17 Microcatheter: Straight Tip, PL17-160-000 ; 45 degree Tip, PL17-160-045; 90 degree Tip, PL17-160-090
Open, Classified
DQYK210601
Aug 25, 2022Boston Scientific Corporation
Boston Scientific Guider Softip XF, 40 XF, 8F, Guide Catheter, REF H965100440
Open, Classified
DQYK010853
K980453
May 25, 2022Cook Incorporated
Pressure Monitoring Set, Single-lumen uncoated central venous catheter. RPN C-PMS-250, GPN G02838
Completed
DQYNone listed
Apr 20, 2022Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
The C304-HIS device features a guide wire to access the vein, a valve to reduce blood loss during the implant procedure, a deflectable catheter to introduce a transvenous device, a catheter dilator to
Open, Classified
DQYK183493
Nov 9, 2021Abbott
Amplatzer Steerable Delivery Sheath
Terminated
DQYK212026
Sep 9, 2021Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
C315-HIS Delivery Catheter
Open, Classified
DQYK101885
Jul 23, 2021Mivi Neuroscience Inc
MIVI Super 90 8F Guide Catheter, 95 cm, REF MIA-9095S-IDE, For Investigational Use Only; sterile, and Super 90 8F Guide Catheter, 90 cm, REF MIA-9090S-IDE, For Investigational Use Only. Device is use
Terminated
DQYK151396
Jul 23, 2021Mivi Neuroscience Inc
MIVI Super 90 Guide Catheters, MIVI Mi-Axus 8F Catheters, REF MIA-9080S (80 cm length); MIA-9090S (90 cm length), and MIA-9095S (95 cm length), MIA-9080-E, MIA-9090S-E, MIA-9095S-E, Sterile. Device i
Terminated
DQYK151396
Apr 21, 2021MICROVENTION INC.
VIA Microcatheter VIA 27 REF VIA-27-154-01 - Product Usage: is a single lumen catheter designed to be introduced over a steerable guidewire into the vasculature.
Terminated
DQYK192135

Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.