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Matreneu Percutaneous Balloon Compression Kit

FDA 510(k)FDA UDI

Class I (US FDA 510(k))

510(k) K220920

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-083513 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-083513 FDA UDI
Primary DI / UDI-DI
06939698601234 FDA UDI
510(k) Number
K220920 FDA 510(k)FDA UDI
FDA Product Code
HAO FDA 510(k)FDA UDI
GMDN Term
Neural-tissue balloon catheter FDA UDI

Classification

Device Class
Class I FDA 510(k)FDA UDI
Legislation / Framework
21 CFR Part 882.4535 FDA 510(k)
Regulation Number
882.4535 FDA 510(k)FDA UDI
Advisory Committee
Neurology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)
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

Matreneu Percutaneous Balloon Compression Kit by Shenzhen Shineyard Medical Device Co. , Ltd. — Class I — FDA_510K — listed in FDA 510(k), FDA GUDID

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Shenzhen Shineyard Medical Device Co. , Ltd.

Sources (2)

  • FDA 510(k) K220920 24 fields · synced Jun 18, 2026
  • FDA UDI e653643e-c57b-421d-a1be-e244350707c5 36 fields · synced May 27, 2026