APRO 55 Swift Catheter and Alembic Aspiration Tubing
FDA 510(k)Class II (US FDA 510(k))
by Alembic, LLC
Identifiers
- 510(k) Number
- K250958 FDA 510(k)
- FDA Product Code
- NRY FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1250 FDA 510(k)
- Regulation Number
- 870.1250 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The APRO 55 Swift Catheter and Alembic Aspiration Tubing is a thrombus retriever catheter system designed for the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease. It is intended for use in the internal carotid, middle cerebral (M1 and M2 segments), basilar, and vertebral arteries within 8 hours of symptom onset. The system combines a flexible aspiration catheter with stainless-steel and coil-plus-braid reinforcement and is used with an aspiration pump and associated tubing to remove thrombus.
The device is supplied as a single-use, sterile system and is intended for use in a clinical setting under the supervision of qualified medical professionals. It is classified as a Class II device by the FDA and is regulated under regulation number 870.1250 for catheter, thrombus retriever. Storage conditions and specific handling instructions are not detailed in the available data. The device has received FDA 510(k) clearance with a determination of substantial equivalence.
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: APRO 55 Swift Catheter and Alembic Aspiration Tubing, APRO®* catheter - Medtronic, APRO 55 Catheter (K250958) | Medical Device Navigator, APRO 55 Swift Catheter and Alembic Aspiration Tubing, K232971 - APRO 55 Catheter and Alembic Aspiration Tubing
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K250958 | Class II | Active |
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Manufacturer
- Manufacturer
- Alembic, LLC
Sources (1)
- FDA 510(k) K250958 24 fields · synced Oct 6, 2026