Finesse BTK Multicath

FDA UDI

Class II (US FDA UDI)

by Summa Therapeutics

Identity

Trade Name: Finesse BTK Multicath FDA UDI
Generic Name: Peripheral angioplasty balloon catheter, basic FDA UDI
Device Name: PTA-2.0-100-065 FDA UDI
Model / Reference: FS201000652 FDA UDI
Description: PTA-2.0-100-065 FDA UDI

Identifiers

Primary DI / UDI-DI: 00810017490653 FDA UDI
FDA Product Code: LIT FDA UDI
KRA FDA UDI
GMDN Term: Peripheral angioplasty balloon catheter, basic FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.1250 FDA UDI
870.1210 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

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Balloon Diameter — 2 Millimeter FDA UDI
Balloon Length — 100 Millimeter FDA UDI
Catheter Working Length — 65 Centimeter FDA UDI

Category: Peripheral angioplasty balloon catheter, basic Angiographic catheter, single-use

Finesse BTK Multicath by Summa Therapeutics — 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: Summa Therapeutics

Sources (1)

FDA UDI ef3d8ad0-85fa-492a-a81c-38b42d6dfc57 35 fields · synced Jun 8, 2026