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Reliant(TM) Multistage Dilatation Balloon Catheter

FDA UDI

Class II (US FDA UDI)

by Micro-Tech (Nanjing) Co., Ltd.

Identity

Trade Name
Reliant(TM) Multistage Dilatation Balloon Catheter FDA UDI
Generic Name
Gastrointestinal/biliary dilation balloon catheter, non-medicated FDA UDI
Device Name
the balloon diameter is 8-9-10mm,the balloon length is 55mm,the catheter diameter is 7 Fr., and the working length is 1800mm,with stainless steel guide wire FDA UDI
Model / Reference
MBD-BM-BA-2 FDA UDI
Description
the balloon diameter is 8-9-10mm,the balloon length is 55mm,the catheter diameter is 7 Fr., and the working length is 1800mm,with stainless steel guide wire FDA UDI

Identifiers

Catalog Number
MBD-BL-BA-2 FDA UDI
Primary DI / UDI-DI
06932503523066 FDA UDI
510(k) Number
K180418 FDA UDI
FDA Product Code
KNQ FDA UDI
FGE FDA UDI
GMDN Term
Gastrointestinal/biliary dilation balloon catheter, non-medicated FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.5365 FDA UDI
876.5010 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Balloon Length — 55 Millimeter FDA UDI

Category: Gastrointestinal/biliary dilation balloon catheter, non-medicated

Reliant(TM) Multistage Dilatation Balloon Catheter by Micro-Tech (Nanjing) Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Gastrointestinal/biliary dilation balloon catheter, non-medicated.

Cleared under the same submission

K180418 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Micro-Tech (Nanjing) Co., Ltd.

Sources (1)

  • FDA UDI cd2b08f7-eac9-4ea7-b6bc-be3398536f83 37 fields · synced May 30, 2026