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Progreat Lambda

FDA 510(k)FDA UDI

Class II (US FDA 510(k))

510(k) K211078

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-MC913AN FDA UDI
Description
Micro Catheter System FDA UDI

Identifiers

Catalog Number
CCM1913AN FDA UDI
Primary DI / UDI-DI
04987350737281 FDA UDI
510(k) Number
K211078 FDA 510(k)FDA UDI
FDA Product Code
DQO FDA 510(k)FDA UDI
KRA FDA UDI
GMDN Term
Vascular microcatheter FDA UDI

Classification

Device Class
Class II FDA 510(k)FDA UDI
Legislation / Framework
21 CFR Part 870.1200 FDA 510(k)
Regulation Number
870.1200 FDA 510(k)FDA UDI
870.1210 FDA UDI
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Catheter Working Length — 130 Centimeter FDA UDI
Outer Diameter — 0.64 Millimeter FDA UDI
Catheter Inner Diameter — 0.48 Millimeter FDA UDI

The Progreat Lambda is an angled microcatheter designed for precise navigation and exceptional torque control in complex vascular procedures. It is specifically engineered to navigate challenging anatomies, including λ-shaped acute curves, with ultra branch selectivity to reach difficult-to-access vessel branches.

The Progreat Lambda is supplied as a single-use device and is intended for use in vascular procedures. It is MRI safe and available in various sizes as specified by the manufacturer. The device has received FDA 510(k) clearance with product code DQO and was reviewed by the Cardiovascular advisory committee.

Frequently asked questions

What is the Progreat Lambda microcatheter designed for?

The Progreat Lambda is an angled microcatheter specifically engineered for precise navigation and exceptional torque control in complex vascular procedures, particularly for navigating challenging anatomies including λ-shaped acute curves with ultra branch selectivity.

Is the Progreat Lambda single-use or reusable?

The Progreat Lambda is supplied as a single-use device and is intended for use in vascular procedures, ensuring sterility and safety for each patient.

What regulatory approvals does the Progreat Lambda have?

The Progreat Lambda has received FDA 510(k) clearance with product code DQO and was reviewed by the Cardiovascular advisory committee, with a decision date of 2021-12-21.

What sizes are available for the Progreat Lambda microcatheter?

The Progreat Lambda is available in various sizes as specified by the manufacturer, allowing clinicians to select the appropriate size for different vascular procedures and anatomical challenges.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PROGREAT LAMBDA™ Microcatheter | Terumo Interventional Systems, Progreat Lambda™ - terumo-europe.com, PROGREAT ALPHA™ Microcatheter | Terumo Interventional Systems, PDF December 21, 2021 Regulatory Affairs Specialist II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Terumo Clinical Supply Co., Ltd.

Sources (2)

  • FDA 510(k) K211078 24 fields · synced Sep 22, 2026
  • FDA UDI c57c47ee-fe20-4b4e-8464-796f990a283f 38 fields · synced May 27, 2026