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FDA 510(k)

PERIPHERAL CUTTING BALLOON

K-Number: K040155 · 2004-07-01

ApplicantBoston Scientific Corp
Decision Date2004-07-01
Product CodePNO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PERIPHERAL CUTTING BALLOON is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corp. It received FDA 510(k) clearance on 2004-07-01 under 510(k) number K040155. 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 PERIPHERAL CUTTING BALLOON?

PERIPHERAL CUTTING BALLOON is a medical device that received FDA 510(k) clearance on 2004-07-01. The listed applicant is Boston Scientific Corp. The 510(k) number is K040155.

When did PERIPHERAL CUTTING BALLOON receive FDA 510(k) clearance?

PERIPHERAL CUTTING BALLOON received FDA 510(k) clearance on 2004-07-01, under 510(k) number K040155.

Who is the listed applicant for PERIPHERAL CUTTING BALLOON?

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

What is the FDA product code for PERIPHERAL CUTTING BALLOON?

The FDA product code for PERIPHERAL CUTTING BALLOON is PNO.

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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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