Modification to Medamicus Axia RSN

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

510(k) Number

K022689 ↗

FDA Product Code

DYB

Device Class

Class II

Regulation

21 CFR Part 870.1340

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Modification to Medamicus Flowguard Peelable Introducer

  Class II

  FDA 510(k) K040150 Active Cleared 18 Feb 2004

• Valved Peelable Introducer

  Class II

  FDA 510(k) K021004 Active Cleared 6 Jun 2002

• Lumax (Modification)

  Class II

  FDA 510(k) K953734 Active Cleared 18 Jan 1996

• Introducer, Percutaneous -- Modification

  Class II

  FDA 510(k) K924491 Active Cleared 18 Nov 1992

• Medamicus Axia RSN

  Class II

  FDA 510(k) K020563 Active Cleared 21 May 2002

• Transducer, Pressure, Catheter Tip

  Class II

  FDA 510(k) K920580 Active Cleared 7 Jan 1993

See all devices from Medamicus, Inc. →

• What is the purpose of the Modification to Medamicus Axia RSN?

  The Modification to Medamicus Axia RSN is an embolization coil designed to occlude blood vessels. It works by being delivered via a catheter to the target site, where it expands and induces clot formation, effectively blocking blood flow to treat conditions such as aneurysms or arteriovenous malformations.

• How is the MedAmicus Axia RSN device used to minimize needle stick injuries?

  The MedAmicus Axia RSN is specifically designed to minimize needle stick injuries when used for percutaneous introduction of guidewires or similar devices. This safety feature makes it particularly valuable in clinical settings where needle stick injuries are a concern.

• What is the regulatory status of the Modification to Medamicus Axia RSN?

  The Modification to Medamicus Axia RSN is a Class II device with product code DYB, cleared by the FDA as substantially equivalent on 2002-08-23. It is manufactured by Medamicus, Inc. and is part of the cardiovascular product category.

• How is the Modification to Medamicus Axia RSN supplied and stored?

  The device is supplied in a sterile condition to ensure safety during medical procedures. It should be stored according to the manufacturer's guidelines to maintain its integrity and functionality until use.