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Indigo System

FDA UDI

Class II (US FDA UDI)

by Penumbra, Inc.

Identity

Trade Name
Indigo System FDA UDI
Generic Name
Thrombectomy suction catheter FDA UDI
Device Name
CAT16 HTORQ 115cm, Select + 135cm BER Tip, Lightning Flash 2.0 Tubing FDA UDI
Model / Reference
LITNGFHT115BER-D FDA UDI
Description
CAT16 HTORQ 115cm, Select + 135cm BER Tip, Lightning Flash 2.0 Tubing FDA UDI

Identifiers

Primary DI / UDI-DI
00815948024267 FDA UDI
510(k) Number
K241399 FDA UDI
FDA Product Code
QEW FDA UDI
GMDN Term
Thrombectomy suction catheter FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.5150 FDA UDI
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

Yes

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

Category: Thrombectomy suction catheterThrombectomy aspiration management software

Indigo System by Penumbra, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Thrombectomy aspiration management software.

Cleared under the same submission

K241399 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Penumbra, Inc.

Sources (1)

  • FDA UDI c8f1231b-be72-4524-9d1e-238d7b63236d 34 fields · synced Jun 8, 2026