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FDA 510(k)

ANGIOSCULPT PTA SCORING BALLOON CATHETER, MODELS 2076-6040, 2092-6040, 2105-6040

K-Number: K091966 · 2009-07-30

ApplicantAngioscore, Inc.
Decision Date2009-07-30
Product CodePNO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ANGIOSCULPT PTA SCORING BALLOON CATHETER, MODELS 2076-6040, 2092-6040, 2105-6040 is the device name listed in this FDA 510(k) record. The listed applicant is Angioscore, Inc.. It received FDA 510(k) clearance on 2009-07-30 under 510(k) number K091966. 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 ANGIOSCULPT PTA SCORING BALLOON CATHETER, MODELS 2076-6040, 2092-6040, 2105-6040?

ANGIOSCULPT PTA SCORING BALLOON CATHETER, MODELS 2076-6040, 2092-6040, 2105-6040 is a medical device that received FDA 510(k) clearance on 2009-07-30. The listed applicant is Angioscore, Inc.. The 510(k) number is K091966.

When did ANGIOSCULPT PTA SCORING BALLOON CATHETER, MODELS 2076-6040, 2092-6040, 2105-6040 receive FDA 510(k) clearance?

ANGIOSCULPT PTA SCORING BALLOON CATHETER, MODELS 2076-6040, 2092-6040, 2105-6040 received FDA 510(k) clearance on 2009-07-30, under 510(k) number K091966.

Who is the listed applicant for ANGIOSCULPT PTA SCORING BALLOON CATHETER, MODELS 2076-6040, 2092-6040, 2105-6040?

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 ANGIOSCULPT PTA SCORING BALLOON CATHETER, MODELS 2076-6040, 2092-6040, 2105-6040?

The FDA product code for ANGIOSCULPT PTA SCORING BALLOON CATHETER, MODELS 2076-6040, 2092-6040, 2105-6040 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-XXYYK082059ANGIOSCULPT PTA SCORING BALLOON CATHETER

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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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