Penumbra System Modified 110 Aspiration Tubing
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- Aspiration Tubing EUDAMEDIndigo System FDA UDI
- Generic Name
- Surgical irrigation/aspiration system FDA UDI
- Device Name
- Penumbra and INDIGO Aspiration Tubing EUDAMEDIndigo 110 Asp Tubing FDA UDI
- Model / Reference
- IST3 EUDAMEDFDA UDISuction/irrigation tubing, single-use EUDAMEDIST4 EUDAMED
- Description
- Indigo 110 Asp Tubing FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810169721070 EUDAMED00810169721087 EUDAMED00814548016214 FDA UDI
- Basic UDI-DI
- 081454801PSINDTUB3G EUDAMED
- FDA Product Code
- NRY FDA 510(k)DXE FDA UDI
- EMDN Code
- C010402020702 MECHANICAL PERIPHERAL THROMBECTOMY AND THROMBOASPIRATION SYSTEMS EUDAMED
- GMDN Term
- Surgical irrigation/aspiration system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 870.1250 FDA 510(k)
- Regulation Number
- 870.1250 FDA 510(k)870.5150 FDA UDI
- Market of Registration
- Germany EUDAMED
- 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
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
Yes
Expiration Date
Yes
Manufacturing Date
No
The Penumbra System Modified 110 Aspiration Tubing is a catheter designed for thrombus retrieval, facilitating the removal of blood clots within vascular systems. It is classified as a thrombus retriever and falls under the category of cardiovascular devices, intended for use in interventional procedures to restore blood flow.
This device is supplied as a single-use, sterile component within the Penumbra System and is regulated under FDA 510K and MDR authorizations. It is intended for use in MRI-safe environments and is available in specific model configurations as referenced by the provided product codes. Storage and handling follow standard sterile medical device protocols to ensure clinical efficacy and safety.
Frequently asked questions
What is the primary purpose of the Penumbra System Modified 110 Aspiration Tubing in clinical settings?
The Penumbra System Modified 110 Aspiration Tubing is specifically designed for thrombus retrieval, meaning it helps remove blood clots from vascular systems during interventional procedures. This aids in restoring proper blood flow, which is critical in treating conditions like strokes or peripheral artery disease where clots obstruct circulation.
Is this device intended for reuse, or is it meant to be used only once per patient?
This device is explicitly labeled as single-use, meaning it is intended for one-time use per patient. Following single-use medical device protocols ensures sterility and safety, preventing cross-contamination between patients.
Can this device be used in an MRI-safe environment, and why is that important?
Yes, the Penumbra System Modified 110 Aspiration Tubing is designed for use in MRI-safe environments. This is important because many patients undergoing thrombus retrieval procedures may require follow-up MRI scans to monitor treatment outcomes or assess complications, and having an MRI-safe device reduces risks like image artifacts or patient injury from magnetic fields.
How should the Penumbra System Modified 110 Aspiration Tubing be stored to maintain its sterility and functionality?
The device should be stored following standard sterile medical device protocols, which typically include keeping it in its original packaging, in a clean, dry environment, and away from direct sunlight or extreme temperatures. This ensures the tubing remains sterile and ready for use when needed, as sterility is critical for preventing infections during vascular procedures.
What regulatory pathways does this device follow, and what does that mean for clinicians or buyers?
The Penumbra System Modified 110 Aspiration Tubing is regulated under both FDA 510K and MDR (Medical Device Regulation) authorizations. This means it has undergone premarket review processes to demonstrate safety and effectiveness, and clinicians or buyers can rely on its compliance with stringent regulatory standards before use in clinical settings.
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.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K182522 | Class II | Active |
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Manufacturer
- Manufacturer
- Penumbra, Inc.
Sources (4)
- FDA 510(k) K182522 24 fields · synced Sep 18, 2026
- FDA UDI 6b7a2483-c4a9-42bd-b376-cf01eeef0325 34 fields · synced May 30, 2026
- EUDAMED f0cdbf58-4f12-4eb6-b7b6-a1131a0c78b0 61 fields · synced Jul 11, 2026
- EUDAMED 0fd38e55-b99c-4741-b582-a9b0e4fd80b9 61 fields · synced Jul 31, 2026