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FDA 510(k)

NOVOSTE VESSEL DILATER

K-Number: K912050 · 1991-10-09

ApplicantNovaste Corp.
Decision Date1991-10-09
Product CodeDRE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

NOVOSTE VESSEL DILATER is the device name listed in this FDA 510(k) record. The listed applicant is Novaste Corp.. It received FDA 510(k) clearance on 1991-10-09 under 510(k) number K912050. The device is classified under product code DRE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NOVOSTE VESSEL DILATER?

NOVOSTE VESSEL DILATER is a medical device that received FDA 510(k) clearance on 1991-10-09. The listed applicant is Novaste Corp.. The 510(k) number is K912050.

When did NOVOSTE VESSEL DILATER receive FDA 510(k) clearance?

NOVOSTE VESSEL DILATER received FDA 510(k) clearance on 1991-10-09, under 510(k) number K912050.

Who is the listed applicant for NOVOSTE VESSEL DILATER?

The FDA 510(k) record lists Novaste Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NOVOSTE VESSEL DILATER?

The FDA product code for NOVOSTE VESSEL DILATER is DRE.

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Related Devices (Code: DRE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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