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FDA 510(k)

MODIFICATION TO ANGIOSCULPT PTA SCORING BALLOON CATHETER

K-Number: K081220 · 2008-05-28

ApplicantAngioscore, Inc.
Decision Date2008-05-28
Product CodePNO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO ANGIOSCULPT PTA SCORING BALLOON CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Angioscore, Inc.. It received FDA 510(k) clearance on 2008-05-28 under 510(k) number K081220. The device is classified under product code PNO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO ANGIOSCULPT PTA SCORING BALLOON CATHETER?

MODIFICATION TO ANGIOSCULPT PTA SCORING BALLOON CATHETER is a medical device that received FDA 510(k) clearance on 2008-05-28. The listed applicant is Angioscore, Inc.. The 510(k) number is K081220.

When did MODIFICATION TO ANGIOSCULPT PTA SCORING BALLOON CATHETER receive FDA 510(k) clearance?

MODIFICATION TO ANGIOSCULPT PTA SCORING BALLOON CATHETER received FDA 510(k) clearance on 2008-05-28, under 510(k) number K081220.

Who is the listed applicant for MODIFICATION TO ANGIOSCULPT PTA SCORING BALLOON CATHETER?

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

What is the FDA product code for MODIFICATION TO ANGIOSCULPT PTA SCORING BALLOON CATHETER?

The FDA product code for MODIFICATION TO ANGIOSCULPT PTA SCORING BALLOON CATHETER is PNO.

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Other records listing Angioscore, Inc. 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.

K122685ANGIOSCULPT PTA SCORING BALLOON CATHETERK112182ANGIOSCULPT PTA SCORING BALLOON CATHETERK110767ANGIOSCULPT PTA SCORING BALLOON CATHETERK101735ANGIOSCULPT PTA SCORING BALLOON CATHETER MODEL 2039-XXYY, 2155-XXYYK100303ANGIOSCULPT PTA SCORING BALLOON CATHETER MODEL 2039-XXYY, 2076-XXYY, 2092-XXYY, 2105-XXYYK091966ANGIOSCULPT PTA SCORING BALLOON CATHETER, MODELS 2076-6040, 2092-6040, 2105-6040

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Related Devices (Code: PNO)

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.

K261778JADE SCORE PTA Scoring Balloon Dilatation CatheterOrbusNeich Medical (Shenzhen) Co., Ltd.K260012UltraScore™ Focused Force PTA BalloonBard Peripheral Vascular, Inc.K243944Aperta NSE PTA Balloon Dilatation CatheterGoodman Co., Ltd.K242254D·Kutting™ LL Peripheral Scoring Balloon Dilatation CatheterDk Medical Technology Co., Ltd.K241478Tri-Wedge PTA Scoring Balloon Dilatation CatheterBrosmed Medical Co., Ltd.K232258XO Constrain™ Percutaneous Transluminal Angioplasty Constraining CatheterTransit Scientific, LLC

Official Source

View on FDA Database →

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

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