Identifiers
- 510(k) Number
- K232542 FDA 510(k)
- FDA Product Code
- QJP 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 Wedge XL Delivery Catheter is a percutaneous, neurovasculature catheter used to assist in the delivery of interventional devices, such as distal access catheters, in the neurovasculature. It is a medical device designed for use in cardiovascular procedures.
The Wedge XL Delivery Catheter is supplied with a product code of QJP and a regulation number of 870.1250. It has been evaluated for substantial equivalence to predicate devices, including the Wedge Microcatheter and the Delivery Catheter of the Route 92 Medical 088 Access System. The device is authorized with an FDA 510(k) clearance.
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: WEDGE™ Delivery Catheter | Terumo Neuro - MicroVention, PDF May 16, 2024 MicroVention, Inc. - Food and Drug Administration, Wedge XL Delivery Catheter (K232542) — FDA 510(k) | Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K232542 | Class II | Active |
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Manufacturer
- Manufacturer
- Microvention Inc.
- FDA Applicant
- MicroVention, Inc.
Sources (1)
- FDA 510(k) K232542 24 fields · synced Sep 27, 2026