Identity
- Trade Name
- Indigo System FDA UDI
- Generic Name
- Thrombectomy suction catheter FDA UDI
- Device Name
- CAT12 100 New HTORQ shape Plus Lightning, CE FDA UDI
- Model / Reference
- LITNG12HTORQ100 FDA UDI
- Description
- CAT12 100 New HTORQ shape Plus Lightning, CE FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00815948022904 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: Suction/irrigation tubing, single-useThrombectomy 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.
- Symphony™ ProHelix™ — IMPERATIVE CARE INC. · Class II
- Prodigy™ Catheter — IMPERATIVE CARE INC. · Class II
- Symphony™ Advance™ Long Dilator — IMPERATIVE CARE INC. · Class II
- Trevo — Stryker Corp.
- Pounce ™ Thrombectomy — Surmodics, Inc. · Class II
- Solitaire™ — Micro Therapeutics, Inc. · Class II
- Stroke Fast Pack — Stryker Corp.
- SmartClaw™ — Boston Scientific · Class II
Cleared under the same submission
K192981 also covers:
- Indigo System — PENUMBRA, INC.
- Indigo System — PENUMBRA, INC.
- Indigo System — PENUMBRA, INC.
- Indigo System — PENUMBRA, INC.
- Indigo System — PENUMBRA, INC.
- Indigo System — PENUMBRA, INC.
- Indigo System — PENUMBRA, INC.
- Indigo System — PENUMBRA, INC.
- Indigo System — PENUMBRA, INC.
- Indigo System — PENUMBRA, INC.
- Indigo System — PENUMBRA, INC.
- Indigo System — PENUMBRA, INC.
K193244 also covers:
- Indigo System — PENUMBRA, INC.
- Indigo System — PENUMBRA, INC.
- Indigo System — PENUMBRA, INC.
- Indigo System — PENUMBRA, INC.
- Indigo System — PENUMBRA, INC.
- Indigo System — PENUMBRA, INC.
- Indigo System — PENUMBRA, INC.
- Indigo System — PENUMBRA, INC.
- Indigo System — PENUMBRA, INC.
- Indigo System — PENUMBRA, INC.
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Penumbra, Inc.
Sources (1)
- FDA UDI d8146882-30d3-434a-9ee4-df85a4e94e89 34 fields · synced Jun 6, 2026