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Medamicus Axia RSN

by Medamicus, Inc.

510(k) K020563

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK020563 Date21 May 2002ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
DYB
Device Class
Class II
Regulation
21 CFR Part 870.1340
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Medamicus Axia RSN is a medical device designed for embolization procedures. It consists of coils that are inserted into blood vessels to obstruct blood flow, effectively treating aneurysms or preventing hemorrhage.

It is intended to minimize needle stick injuries when used for percutaneous introduction of guidewires or similar devices. The device is supplied by Medamicus, Inc., has FDA 510(k) clearance under K020563, and is classified under product code DYB with a traditional clearance type and cardiovascular advisory committee review.

Other devices from Medamicus, Inc.

See all devices from Medamicus, Inc. →

Questions

AI-generated answers, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Medamicus Axia RSN used for?

    The Medamicus Axia RSN is designed for embolization procedures, where coils are inserted into blood vessels to obstruct blood flow. This helps treat aneurysms or prevent hemorrhage by blocking abnormal or dangerous blood flow in targeted vessels.

  • How is the Medamicus Axia RSN supplied and is it sterile?

    The device is supplied by Medamicus, Inc. While the data does not explicitly state sterility, embolization coils are typically provided sterile for single-use in percutaneous procedures to prevent infection and ensure patient safety during vascular access.

  • What regulatory pathway was used for the Medamicus Axia RSN?

    The Medamicus Axia RSN received FDA 510(k) clearance under submission number K020563, with a traditional clearance type and review by the cardiovascular advisory committee. It was found substantially equivalent to a predicate device, as indicated by the decision code SESE.