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FDA 510(k)

POLARCATH PERIPHERAL DILATATION SYSTEM

K-Number: K071042 · 2007-06-13

ApplicantBoston Scientific Corp
Decision Date2007-06-13
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

POLARCATH PERIPHERAL DILATATION SYSTEM 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 2007-06-13 under 510(k) number K071042. The device is classified under product code LIT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POLARCATH PERIPHERAL DILATATION SYSTEM?

POLARCATH PERIPHERAL DILATATION SYSTEM is a medical device that received FDA 510(k) clearance on 2007-06-13. The listed applicant is Boston Scientific Corp. The 510(k) number is K071042.

When did POLARCATH PERIPHERAL DILATATION SYSTEM receive FDA 510(k) clearance?

POLARCATH PERIPHERAL DILATATION SYSTEM received FDA 510(k) clearance on 2007-06-13, under 510(k) number K071042.

Who is the listed applicant for POLARCATH PERIPHERAL DILATATION SYSTEM?

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 POLARCATH PERIPHERAL DILATATION SYSTEM?

The FDA product code for POLARCATH PERIPHERAL DILATATION SYSTEM is LIT.

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Related Devices (Code: LIT)

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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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