FDA.reportPublic FDA data

Teleport XT Microcatheter

Primary DI
06934955915970
Brand
Teleport XT Microcatheter
Company
OrbusNeich Medical (ShenZhen) Co., Ltd.
Model
7321-135-01
Device description
Catheter, Percutaneous
Published
2025-03-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
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
K231608000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K231608000Teleport XT MicrocatheterOrbusNeich Medical (Shenzhen) Co., Ltd.2024-01-07DQY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06934955915970PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06934955915970069349559159706934955915970

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06934955934742COREPASS Modular Microcatheter8425-150-022025-03-20
06934955934728COREPASS Modular Microcatheter8422-150-022025-03-01
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
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
Primary DIBrandCompanyProduct codePublished
00810024671953SSPC NXT Delivery CatheterCENTERPOINT SYSTEMS LLCDQY2026-06-01
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07613327623338AXS LiftStryker CorporationDQY2025-03-04
07613327623376AXS LiftStryker CorporationDQY2025-03-04
00842429106563Balloon CatheterMicrovention, Inc.DQY2022-06-14
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