← Back to catalogue

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
Separator 7, 190cm FDA UDI
Model / Reference
SEP7160-A FDA UDI
Description
Separator 7, 190cm FDA UDI

Identifiers

Primary DI / UDI-DI
00815948021716 FDA UDI
510(k) Number
K210083 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

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

Category: Thrombectomy suction catheter

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

Similar devices

Also classified as Thrombectomy suction catheter.

Cleared under the same submission

K210083 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Penumbra, Inc.

Sources (1)

  • FDA UDI fe5c4351-e119-493e-9a96-3ee34d5b15c6 34 fields · synced Jun 1, 2026