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Matreneu® Percutaneous Balloon Compression Kit

FDA UDI

Class I (US FDA UDI)

by Shenzhen Shineyard Medical Device Co. , Ltd.

Identity

Trade Name
Matreneu® Percutaneous Balloon Compression Kit FDA UDI
Generic Name
Neural-tissue balloon catheter FDA UDI
Device Name
This product primarily consists of five parts, i.e. the balloon catheter, puncture needle, syringe, connector, and pressure gauge. FDA UDI
Model / Reference
PBCS-108013 FDA UDI
Description
This product primarily consists of five parts, i.e. the balloon catheter, puncture needle, syringe, connector, and pressure gauge. FDA UDI

Identifiers

Catalog Number
PBCS-108013 FDA UDI
Primary DI / UDI-DI
06939698601388 FDA UDI
510(k) Number
K220920 FDA UDI
FDA Product Code
HAO FDA UDI
GMDN Term
Neural-tissue balloon catheter FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
882.4535 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

Yes

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

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Neural-tissue balloon catheter

Matreneu® Percutaneous Balloon Compression Kit by Shenzhen Shineyard Medical Device Co. , Ltd. — Class I — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Neural-tissue balloon catheter.

Cleared under the same submission

K220920 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Shenzhen Shineyard Medical Device Co. , Ltd.

Sources (1)

  • FDA UDI b5f2d093-a771-4d86-acc6-95e38ef45d1a 36 fields · synced May 30, 2026