FDA.reportPublic FDA data

COREPASS Modular Microcatheter

Primary DI
06934955934735
Brand
COREPASS Modular Microcatheter
Company
OrbusNeich Medical (ShenZhen) Co., Ltd.
Model
8425-135-02
Published
2025-03-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DQYCatheter, Percutaneous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQYCatheter, PercutaneousCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K242588000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K242588000COREPASS Modular Microcatheter (FLEX); COREPASS Modular Microcatheter (CONTROL)OrbusNeich Medical (Shenzhen) Co., Ltd.2025-01-07DQY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06934955934735PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06934955934735069349559347356934955934735

GMDN Terms#

Term, Definition table
TermDefinition
Vascular microcatheterA sterile, small-diameter, single-lumen, flexible tube designed for the controlled infusion of fluids (e.g., thrombolytics, diagnostic contrast media) into superselective small vessels (including intracranial, peripheral, or occluded coronary vasculature) for angiography/treatment, and typically also for the delivery of devices (e.g., embolization implants, guidewires) into tortuous vessels or across tight lesions. It may include an ultrasound transducer, a thermal sensor, and a hole for guidewire placement located at the distal tip. It is not a guide-catheter (i.e., is not intended to deliver other catheters or therapeutic leads directly through its lumen). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
530923226
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06934955914713Teleport Glide Microcatheter9218-090-012026-07-20
06934955914720Teleport Glide Microcatheter9218-135-012026-07-20
06934955914737Teleport Glide Microcatheter9218-150-012026-07-20
06934955914744Teleport Glide Microcatheter9218-180-012026-07-20
06934955914751Teleport Glide Microcatheter9218-200-012026-07-20
06934955914768Teleport Glide Microcatheter9235-065-012026-07-20
06934955914775Teleport Glide Microcatheter9235-090-012026-07-20
06934955914782Teleport Glide Microcatheter9235-135-012026-07-20
06934955914799Teleport Glide Microcatheter9235-150-012026-07-20
06934955914805Teleport Glide Microcatheter9235-180-012026-07-20
06934955914812Teleport Glide Microcatheter9235-200-012026-07-20
06934955914829Teleport Glide Microcatheter9218-090-112026-07-20
06934955914836Teleport Glide Microcatheter9218-135-112026-07-20
06934955914843Teleport Glide Microcatheter9218-150-112026-07-20
06934955914850Teleport Glide Microcatheter9218-180-112026-07-20
06934955914867Teleport Glide Microcatheter9218-200-112026-07-20
06934955914874Teleport Glide Microcatheter9235-065-112026-07-20
06934955914881Teleport Glide Microcatheter9235-090-112026-07-20
06934955914898Teleport Glide Microcatheter9235-135-112026-07-20
06934955914904Teleport Glide Microcatheter9235-150-112026-07-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450416723SureCrossMerit Medical Systems, Inc.DQY2026-09-22
00884450422755SureCrossMerit Medical Systems, Inc.DQY2026-09-22
00884450423110SureCrossMerit Medical Systems, Inc.DQY2026-09-22
00884450427170SureCrossMerit Medical Systems, Inc.DQY2026-09-22
10886704074892ENVOYCerenovus, Inc.DQY2026-09-19
10841156108267TRAPLINERTELEFLEX INCORPORATEDDQY2026-08-18
00199150070114NAMEDTRONIC, INC.DQY2026-04-13
00199150070121NAMEDTRONIC, INC.DQY2026-04-13
00199150070138NAMEDTRONIC, INC.DQY2026-04-13
00199150070145NAMEDTRONIC, INC.DQY2026-04-13
00843152100057IOPS Visionary SystemCenterline Biomedical, Inc.DQY2026-02-24
08718122013984Primum Guiding CatheterPendraCare International B.V.DQY2026-02-02
08718122028896Primum Guiding CatheterPendraCare International B.V.DQY2026-02-02
08718122013915Primum Guiding CatheterPendraCare International B.V.DQY2026-02-02
10841156111878TURNPIKETELEFLEX INCORPORATEDDQY2025-09-09
10841156111250GUIDELINERTELEFLEX INCORPORATEDDQY2025-07-14
00195451000836Shockwave CS Guide CatheterShockwave Medical, Inc.DQY2025-06-02
10801902217773ARROWTELEFLEX INCORPORATEDDQY2024-04-08
10801902217988ARROWTELEFLEX INCORPORATEDDQY2024-03-18
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00191506019587Rubicon™ ControlBOSTON SCIENTIFIC CORPORATIONDQY2024-02-16
00191506019600Rubicon™ ControlBOSTON SCIENTIFIC CORPORATIONDQY2024-02-16
00191506019624Rubicon™ ControlBOSTON SCIENTIFIC CORPORATIONDQY2024-02-16
00191506019648Rubicon™ ControlBOSTON SCIENTIFIC CORPORATIONDQY2024-02-16
00191506019662Rubicon™ ControlBOSTON SCIENTIFIC CORPORATIONDQY2024-02-16
00191506019686Rubicon™ ControlBOSTON SCIENTIFIC CORPORATIONDQY2024-02-16
00191506019709Rubicon™ ControlBOSTON SCIENTIFIC CORPORATIONDQY2024-02-16
00191506019723Rubicon™ ControlBOSTON SCIENTIFIC CORPORATIONDQY2024-02-16
00191506019747Rubicon™ ControlBOSTON SCIENTIFIC CORPORATIONDQY2024-02-16
00191506019761Rubicon™ ControlBOSTON SCIENTIFIC CORPORATIONDQY2024-02-16