TSP Crosser Transseptal Access System

FDA UDI

Class II (US FDA UDI)

by Transseptal Solutions , Ltd.

Identity

Trade Name: TSP Crosser Transseptal Access System FDA UDI
Generic Name: Cardiac transseptal access set FDA UDI
Device Name: The TSP Crosser System is intended to be used both to puncture the interatrial septum during a transseptal catheterization procedure and to introduce various cardiovascular catheters into the left heart chambers. FDA UDI
Model / Reference: TSUS001 FDA UDI
Description: The TSP Crosser System is intended to be used both to puncture the interatrial septum during a transseptal catheterization procedure and to introduce various cardiovascular catheters into the left heart chambers. FDA UDI

Identifiers

Primary DI / UDI-DI: 07290017811017 FDA UDI
FDA Product Code: DYB FDA UDI
GMDN Term: Cardiac transseptal access set FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.1340 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 transseptal access set

TSP Crosser Transseptal Access System by Transseptal Solutions , 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: Transseptal Solutions , Ltd.

Sources (1)

FDA UDI 03fdc336-461d-432c-b1b2-b6e6edd6471c 35 fields · synced May 30, 2026