Identifiers
- 510(k) Number
- K142014 FDA 510(k)
- FDA Product Code
- DQY 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 Sofia Distal Access Catheter is a neurovascular distal access catheter in the Access & Support Catheters family. It is used by interventional specialists in procedures where a neurovascular distal access catheter of this class is required.
The device is supplied by MicroVention, Inc. and has received FDA 510(k) clearance under K142014 with product code DQY. It is intended for use in neurovascular procedures as part of the manufacturer's access catheter family.
Frequently asked questions
What is the Sofia Distal Access Catheter used for?
The Sofia Distal Access Catheter is used by interventional specialists in neurovascular procedures where a distal access catheter of this class is required, as part of MicroVention's Access & Support Catheters family.
How is the Sofia Distal Access Catheter supplied and by whom?
The device is supplied by MicroVention, Inc. and is provided as a sterile, single-use catheter intended for neurovascular access during interventional procedures.
What regulatory clearance does the Sofia Distal Access Catheter have?
The Sofia Distal Access Catheter has received FDA 510(k) clearance under submission number K142014, with product code DQY, and was found substantially equivalent to a predicate device.
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: SOFIA™ | Terumo Neuro - MicroVention, PDF Summary of Safety and Clinical Performance for SOFIATM Catheter Family ..., SOFIA™ (DA5115ST) Neurovascular distal access catheter — Specifications ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K142014 | Class II | Active |
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Manufacturer
- Manufacturer
- Microvention Inc.
- FDA Applicant
- MicroVention, Inc.
Sources (1)
- FDA 510(k) K142014 24 fields · synced Sep 28, 2026