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FDA 510(k)

SYMMETRY BALLOON DILATATION CATHETER

K-Number: K060959 · 2006-04-12

ApplicantBoston Scientific Corporation
Decision Date2006-04-12
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SYMMETRY BALLOON DILATATION CATHETER 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 2006-04-12 under 510(k) number K060959. 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 SYMMETRY BALLOON DILATATION CATHETER?

SYMMETRY BALLOON DILATATION CATHETER is a medical device that received FDA 510(k) clearance on 2006-04-12. The listed applicant is Boston Scientific Corporation. The 510(k) number is K060959.

When did SYMMETRY BALLOON DILATATION CATHETER receive FDA 510(k) clearance?

SYMMETRY BALLOON DILATATION CATHETER received FDA 510(k) clearance on 2006-04-12, under 510(k) number K060959.

Who is the listed applicant for SYMMETRY BALLOON DILATATION CATHETER?

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 SYMMETRY BALLOON DILATATION CATHETER?

The FDA product code for SYMMETRY BALLOON DILATATION CATHETER 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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