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Sedat Myshell Lite

by Sedat

510(k) K080472

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 · Special NumberK080472 Date23 Apr 2008ClearedStatusActive

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  • Withdrawn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
DTL
Device Class
Class II
Regulation
21 CFR Part 870.4290
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

The Sedat Myshell Lite is a Y-connector device featuring a double silicone hemostatic valve within a reduced volume housing. It is designed for use during interventional angioplasty procedures to assist, manipulate and maintain a seal around diagnostic/interventional devices with an outside diameter less than 9F.

The device includes a thumb-activated control button that adjusts the geometry of the silicone membrane, allowing the clinician to enlarge the valve opening. It is supplied as a single-use device and is authorized under FDA 510(k) clearance with product code DTL. The device is not indicated for MRI use.

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