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FDA 510(k)

MODIFICATION TO: POLARCATH PERIPHERAL DILATATION SYSTEM

K-Number: K092455 · 2009-09-04

ApplicantBoston Scientific Corporation
Decision Date2009-09-04
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO: POLARCATH PERIPHERAL DILATATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corporation. It received FDA 510(k) clearance on 2009-09-04 under 510(k) number K092455. 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 MODIFICATION TO: POLARCATH PERIPHERAL DILATATION SYSTEM?

MODIFICATION TO: POLARCATH PERIPHERAL DILATATION SYSTEM is a medical device that received FDA 510(k) clearance on 2009-09-04. The listed applicant is Boston Scientific Corporation. The 510(k) number is K092455.

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

MODIFICATION TO: POLARCATH PERIPHERAL DILATATION SYSTEM received FDA 510(k) clearance on 2009-09-04, under 510(k) number K092455.

Who is the listed applicant for MODIFICATION TO: POLARCATH PERIPHERAL DILATATION SYSTEM?

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

What is the FDA product code for MODIFICATION TO: POLARCATH PERIPHERAL DILATATION SYSTEM?

The FDA product code for MODIFICATION TO: POLARCATH PERIPHERAL DILATATION SYSTEM is 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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