Bendit®21 Microcatheter

FDA UDI

Class II (US FDA UDI)

by Bend IT Technologies, Ltd.

Identity

Trade Name: Bendit®21 Microcatheter FDA UDI
Generic Name: Vascular microcatheter FDA UDI
Device Name: The Bendit®21 Microcatheter is intended for use in accessing target locations in the peripheral, coronary, and neuro vasculature and can be used to deliver both diagnostic agents, such as contrast media, and therapeutic devices. Use only contrast media and therapeutic devices that have been cleared or approved for use in the intended target area. FDA UDI
Model / Reference: BDT21157U2 FDA UDI
Description: The Bendit®21 Microcatheter is intended for use in accessing target locations in the peripheral, coronary, and neuro vasculature and can be used to deliver both diagnostic agents, such as contrast media, and therapeutic devices. Use only contrast media and therapeutic devices that have been cleared or approved for use in the intended target area. FDA UDI

Identifiers

Primary DI / UDI-DI: 17290018072049 FDA UDI
510(k) Number: K203842 FDA UDI
FDA Product Code: QJP FDA UDI
DQY FDA UDI
GMDN Term: Vascular microcatheter FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.1250 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

Yes

FDA UDI

Category: Vascular microcatheter

Bendit®21 Microcatheter by Bend IT Technologies, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Vascular microcatheter.

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Renegade™ HI-FLO™ Kit — Boston Scientific · Class II
PROWLER — Medos International Sàrl · Class II
Merit Maestro® — Merit Medical Systems, Inc. · Class II
Lantern Delivery Catheter — PENUMBRA, INC. · Class II
Direxion™ Fathom™-16 System — Boston Scientific · Class II

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: Bend IT Technologies, Ltd.

Sources (1)

FDA UDI 000629eb-7efb-4412-af02-11bc5fdddc77 36 fields · synced Jun 6, 2026