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Novoste Vessel Dilater

by Novaste Corp.

510(k) K912050

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 NumberK912050 Date9 Oct 1991ClearedStatusActive

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  • Withdrawn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
DRE
Device Class
Class II
Regulation
21 CFR Part 870.1310
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 Novoste Vessel Dilater is a vessel dilator intended for percutaneous catheterization. It is classified as a cardiovascular device designed to assist in the dilation of vessels during clinical procedures.

This device is regulated under 21 CFR 870.1310 and has received FDA 510(k) clearance under the number K912050. It is manufactured by Novoste Corp. and is categorized within the cardiovascular medical specialty.

Questions

AI-generated answers, 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.

  • What is the primary clinical use of the Novoste Vessel Dilater?

    The Novoste Vessel Dilater is a cardiovascular device specifically intended to assist in the dilation of vessels during percutaneous catheterization procedures.

  • Is this device regulated by the FDA?

    Yes, the Novoste Vessel Dilater is regulated under 21 CFR 870.1310 and has received FDA 510(k) clearance under the number K912050.

  • Who is the manufacturer of this vessel dilator?

    The Novoste Vessel Dilater is manufactured by Novoste Corp., based in Aguadilla, Puerto Rico.