← Back to catalogue

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-085013 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-085013 FDA UDI
Primary DI / UDI-DI
06939698601265 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Shenzhen Shineyard Medical Device Co. , Ltd.

Sources (1)

  • FDA UDI ec8ecdbe-ff55-4e3b-b090-165608884b4d 36 fields · synced May 30, 2026