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FDA 510(k)

OPTIMUS 0.035 PTA BALLOON DILATATION CATHETER

K-Number: K082646 · 2008-11-03

ApplicantUsci Ireland
Decision Date2008-11-03
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

OPTIMUS 0.035 PTA BALLOON DILATATION CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Usci Ireland. It received FDA 510(k) clearance on 2008-11-03 under 510(k) number K082646. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPTIMUS 0.035 PTA BALLOON DILATATION CATHETER?

OPTIMUS 0.035 PTA BALLOON DILATATION CATHETER is a medical device that received FDA 510(k) clearance on 2008-11-03. The listed applicant is Usci Ireland. The 510(k) number is K082646.

When did OPTIMUS 0.035 PTA BALLOON DILATATION CATHETER receive FDA 510(k) clearance?

OPTIMUS 0.035 PTA BALLOON DILATATION CATHETER received FDA 510(k) clearance on 2008-11-03, under 510(k) number K082646.

Who is the listed applicant for OPTIMUS 0.035 PTA BALLOON DILATATION CATHETER?

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

What is the FDA product code for OPTIMUS 0.035 PTA BALLOON DILATATION CATHETER?

The FDA product code for OPTIMUS 0.035 PTA BALLOON DILATATION CATHETER is DQY.

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Other records listing Usci Ireland as applicant

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.

K072156OPTIMUS 0.035 INCH PTA BALLOON DILATATION CATHETER

Related Devices (Code: DQY)

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.

K262817CrossFAST Integrated Microcatheter Advanced Delivery SystemVantis Vascular, Inc.K260559NHanceITIMDS Operation B.V.K262392APRO 35 Swift CatheterAlembic, LLCK262240SSPC NXT Delivery CatheterCenterPoint Systems, LLCK261766CPS Locator 3D Plus Delivery CatheterCenterPoint Systems, LLCK261825Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP CatheterAbbott

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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