FDA.reportPublic FDA data

COREPASS Modular Microcatheter

Primary DI
06934955934728
Brand
COREPASS Modular Microcatheter
Company
OrbusNeich Medical (ShenZhen) Co., Ltd.
Model
8422-150-02
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
06934955934728PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06934955934728069349559347286934955934728

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
06934955934742COREPASS Modular Microcatheter8425-150-022025-03-20
06934955934735COREPASS Modular Microcatheter8425-135-022025-03-01
06934955934711COREPASS Modular Microcatheter8422-135-022025-03-01
06934955916960Teleport XT Microcatheter7321-090-017321-090-012024-01-25
06934955916977Teleport XT Microcatheter7321-135-017321-135-012024-01-25
06934955916984Teleport XT Microcatheter7321-150-017321-150-012024-01-25
06934955915963Teleport XT Microcatheter7321-090-012025-03-01
06934955915970Teleport XT Microcatheter7321-135-012025-03-01
06934955915987Teleport XT Microcatheter7321-150-012025-03-01
06934955979019Sapphire ULTRA Coronary Dilatation Catheter7910-005-112025-02-20
06934955979026Sapphire ULTRA Coronary Dilatation Catheter7910-008-112025-02-20
06934955979033Sapphire ULTRA Coronary Dilatation Catheter7910-010-112025-02-20
06934955979040Sapphire ULTRA Coronary Dilatation Catheter7910-015-112025-02-20
06934955979057Sapphire ULTRA Coronary Dilatation Catheter7912-005-112025-02-20
06934955979064Sapphire ULTRA Coronary Dilatation Catheter7912-008-112025-02-20
06934955979071Sapphire ULTRA Coronary Dilatation Catheter7912-010-112025-02-20
06934955979088Sapphire ULTRA Coronary Dilatation Catheter7912-015-112025-02-20
06934955979095Sapphire ULTRA Coronary Dilatation Catheter7915-010-112025-02-20
06934955979101Sapphire ULTRA Coronary Dilatation Catheter7915-012-112025-02-20
06934955979118Sapphire ULTRA Coronary Dilatation Catheter7915-015-112025-02-20

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Primary DI, Brand, Company table
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07613327623338AXS LiftStryker CorporationDQY2025-03-04
07613327623376AXS LiftStryker CorporationDQY2025-03-04
00842429106563Balloon CatheterMicrovention, Inc.DQY2022-06-14
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