FDA.reportPublic FDA data

Teleport Glide Microcatheter

Primary DI
06934955914799
Brand
Teleport Glide Microcatheter
Company
OrbusNeich Medical (ShenZhen) Co., Ltd.
Model
9235-150-01
Published
2026-07-20
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
K253361000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K253361000Teleport Glide MicrocatheterOrbusNeich Medical (Shenzhen) Co., Ltd.2026-04-10DQY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06934955914799PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06934955914799069349559147996934955914799

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.

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
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
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
06934955914911Teleport Glide Microcatheter9235-180-112026-07-20

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10841156108267TRAPLINERTELEFLEX INCORPORATEDDQY2026-08-18
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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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