Progreat Lambda

FDA UDI

Class II (US FDA UDI)

by Terumo Clinical Supply Co., Ltd.

Identity

Trade Name: Progreat Lambda FDA UDI
Generic Name: Vascular microcatheter FDA UDI
Device Name: Micro Catheter System FDA UDI
Model / Reference: CC*M1916AN FDA UDI
Description: Micro Catheter System FDA UDI

Identifiers

Catalog Number: CCM1916AN FDA UDI
Primary DI / UDI-DI: 04987350741004 FDA UDI
510(k) Number: K211078 FDA UDI
FDA Product Code: DQO FDA UDI
GMDN Term: Vascular microcatheter FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.1200 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: Length — 165 Centimeter FDA UDI
Catheter Inner Diameter — 0.48 Millimeter FDA UDI
Outer Diameter — 0.64 Millimeter FDA UDI

Category: Vascular microcatheter

Progreat Lambda by Terumo Clinical Supply Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Vascular microcatheter.

Velocity Delivery Microcatheter — PENUMBRA, INC. · Class II
Knight Microcatheter — ZIEN Medical Technologies, LLC · Class II
Merit Pursue™ — Merit Medical Systems, Inc. · Class I
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

Cleared under the same submission

K211078 also covers:

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: Terumo Clinical Supply Co., Ltd.

Sources (1)

FDA UDI d118481f-089a-4856-a368-22943033af8f 38 fields · synced Jun 1, 2026