Skip to content

Meadox Surgimed Olbert Catheter System Noprofile

by Meadox Medicals, Div. Boston Scientific Corp.

510(k) K934411

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 NumberK934411 Date7 Jan 1994ClearedStatusActive

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  • Withdrawn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
LIT
Device Class
Class II
Regulation
21 CFR Part 870.1250
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 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 MEADOX SURGIMED OLBERT CATHETER SYSTEM NOPROFILE is a peripheral transluminal angioplasty catheter designed for vascular intervention procedures. It is classified under product code LIT as a Class II catheter, angioplasty, peripheral, transluminal device, and is intended for use in cardiovascular applications.

The device is supplied by Meadox Medicals, Div. Boston Scientific Corp., and was cleared via FDA 510(k) premarket notification under regulation number 870.1250. It is a single-use, sterile device intended for clinical settings requiring peripheral angioplasty. The system is evaluated for substantial equivalence and falls under the Cardiovascular advisory committee review category.

Other devices from Meadox Medicals, Div. Boston Scientific Corp.

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