FDA.reportPublic FDA data

510(k) K253361

Device
Teleport Glide Microcatheter
Applicant
OrbusNeich Medical (Shenzhen) Co., Ltd.
510(k) number
K253361
Product code
DQY
Decision
Substantially Equivalent (SESE)
Decision date
2026-04-10
Date received
2025-09-30
Regulation
870.1250
Classification name
Catheter, Percutaneous
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Dora Zhang
Address
#1 Jinkui Rd. Futian Free Trade Zone Shenzhen CN 518038 518038

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code DQY#

510(k), Device, Applicant table
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K243184SAT CenterFlow Molding Balloon Catheter (IN20-00313)Strait Access Technologies Holdings2025-06-25
K250492FlexiGo 3D Delivery CatheterCenterPoint Systems, LLC2025-06-18
K250219Dorado™ PTA Balloon Dilatation CatheterBard Peripheral Vascular, Inc.2025-06-17