ShortCut

FDA UDI

Class II (US FDA UDI)

by Pi-Cardia, Ltd.

Identity

Trade Name: ShortCut FDA UDI
Generic Name: Cardiac valvuloplasty catheter FDA UDI
Device Name: Percutaneous catheter for cutting or splitting heart valve leaflets concomitant to transcatheter valve procedures. FDA UDI
Model / Reference: Z-A-20.003-US FDA UDI
Description: Percutaneous catheter for cutting or splitting heart valve leaflets concomitant to transcatheter valve procedures. FDA UDI

Identifiers

Primary DI / UDI-DI: 07290020101242 FDA UDI
510(k) Number: DEN240017 FDA UDI
FDA Product Code: SCZ FDA UDI
GMDN Term: Cardiac valvuloplasty catheter FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.1254 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Cardiac valvuloplasty catheter

ShortCut by Pi-Cardia, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Pi-Cardia, Ltd.

Sources (1)

FDA UDI b17f597f-4208-40a5-b9bf-fdaa13a41942 35 fields · synced Jun 8, 2026