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FDA 510(k)

PERIPHERAL CUTTING BALLOON

K-Number: K051254 · 2005-06-22

ApplicantBoston Scientific Ivt
Decision Date2005-06-22
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 Ivt. It received FDA 510(k) clearance on 2005-06-22 under 510(k) number K051254. 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 2005-06-22. The listed applicant is Boston Scientific Ivt. The 510(k) number is K051254.

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

PERIPHERAL CUTTING BALLOON received FDA 510(k) clearance on 2005-06-22, under 510(k) number K051254.

Who is the listed applicant for PERIPHERAL CUTTING BALLOON?

The FDA 510(k) record lists Boston Scientific Ivt 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.

Related Clinical Trials

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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Other records listing Boston Scientific Ivt 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.

K0419932 CM PERIPHERAL CUTTING BALOON

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.

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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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