Meadox Surgimed Balloon Catheter

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

510(k) Number

K923947 ↗

FDA Product Code

LIT

Device Class

Class II

Regulation

21 CFR Part 870.1250

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Cardiac Electrode K760443

  Class III

  FDA 510(k) K760443 Active Cleared 26 Aug 1976

• Meadox Exxcel Eptfe Vascular Graft

  Class II

  FDA 510(k) K962433 Active Cleared 17 Mar 1997

• Ms Classique Balloon Catheter

  Class II

  FDA 510(k) K942293 Active Cleared 18 Oct 1994

• Meadox(R) Surgimed Olbert Catheter System(R)

  Class II

  FDA 510(k) K921706 Active Cleared 20 May 1993

• Naviguide Hydrophilic Guide Wire

  Class II

  FDA 510(k) K943358 Active Cleared 2 Jun 1995

• Hemashield Microvel Velour Knitted Vascular Graft

  Class II

  FDA 510(k) K954848 Active Cleared 1 Feb 1996

See all devices from Meadox Medicals, Div. Boston Scientific Corp. →

• What is the Meadox Surgimed Balloon Catheter used for?

  The Meadox Surgimed Balloon Catheter is used in cardiovascular medical specialty for peripheral transluminal procedures.

• What is the regulatory classification of the Meadox Surgimed Balloon Catheter?

  The Meadox Surgimed Balloon Catheter is classified as a class 2 device with an FDA 510K authorization.

• What is the product code of the Meadox Surgimed Balloon Catheter?

  The product code of the Meadox Surgimed Balloon Catheter is LIT, with a regulation number of 870.1250.