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FDA 510(k)

SMALL PERIPHERAL CUTTING BALLON, MONORAIL DELIVERY SYSTEM

K-Number: K062387 · 2006-10-05

ApplicantBoston Scientific
Decision Date2006-10-05
Product CodePNO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SMALL PERIPHERAL CUTTING BALLON, MONORAIL DELIVERY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific. It received FDA 510(k) clearance on 2006-10-05 under 510(k) number K062387. 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 SMALL PERIPHERAL CUTTING BALLON, MONORAIL DELIVERY SYSTEM?

SMALL PERIPHERAL CUTTING BALLON, MONORAIL DELIVERY SYSTEM is a medical device that received FDA 510(k) clearance on 2006-10-05. The listed applicant is Boston Scientific. The 510(k) number is K062387.

When did SMALL PERIPHERAL CUTTING BALLON, MONORAIL DELIVERY SYSTEM receive FDA 510(k) clearance?

SMALL PERIPHERAL CUTTING BALLON, MONORAIL DELIVERY SYSTEM received FDA 510(k) clearance on 2006-10-05, under 510(k) number K062387.

Who is the listed applicant for SMALL PERIPHERAL CUTTING BALLON, MONORAIL DELIVERY SYSTEM?

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

What is the FDA product code for SMALL PERIPHERAL CUTTING BALLON, MONORAIL DELIVERY SYSTEM?

The FDA product code for SMALL PERIPHERAL CUTTING BALLON, MONORAIL DELIVERY SYSTEM is PNO.

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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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