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Flo-Rester Vessel Sizer

by Bio-Vascular, Inc.

510(k) K905159

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK905159 Date7 Feb 1991ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

Full name
Flo-Rester(R) Vessel Sizer
510(k) Number
FDA Product Code
DWP
Device Class
Class II
Regulation
21 CFR Part 870.4475
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 Flo-Rester Vessel Sizer is a surgical vessel dilator used for measuring and sizing blood vessels during cardiovascular procedures. It is designed to assist surgeons in determining the appropriate size for vessel dilation or stent placement.

This device is supplied as a single-use or reusable instrument, depending on the specific model, and is not MRI compatible. It is manufactured by Bio-Vascular, Inc. and has FDA 510(k) clearance with the product code DWP, classified under device class 2 for cardiovascular applications.

Other devices from Bio-Vascular, Inc.

See all devices from Bio-Vascular, 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 Flo-Rester Vessel Sizer used for?

    The Flo-Rester Vessel Sizer is a surgical vessel dilator designed to assist surgeons in measuring and sizing blood vessels during cardiovascular procedures, helping determine appropriate vessel dilation or stent placement.

  • Is the Flo-Rester Vessel Sizer single-use or reusable?

    The Flo-Rester Vessel Sizer is supplied as either a single-use or reusable instrument, depending on the specific model selected for the procedure.

  • What regulatory approvals does the Flo-Rester Vessel Sizer have?

    The Flo-Rester Vessel Sizer has FDA 510(k) clearance with product code DWP, classified under device class 2 for cardiovascular applications, and is manufactured by Bio-Vascular, Inc.

  • Is the Flo-Rester Vessel Sizer MRI compatible?

    No, the Flo-Rester Vessel Sizer is not MRI compatible, as specified in the device description.