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FDA 510(k)

ONE-PIECE SHUNT

K-Number: K834593 · 1984-04-03

ApplicantAmerican Heyer Schulte
Decision Date1984-04-03
Product CodeJXG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ONE-PIECE SHUNT is the device name listed in this FDA 510(k) record. The listed applicant is American Heyer Schulte. It received FDA 510(k) clearance on 1984-04-03 under 510(k) number K834593. The device is classified under product code JXG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ONE-PIECE SHUNT?

ONE-PIECE SHUNT is a medical device that received FDA 510(k) clearance on 1984-04-03. The listed applicant is American Heyer Schulte. The 510(k) number is K834593.

When did ONE-PIECE SHUNT receive FDA 510(k) clearance?

ONE-PIECE SHUNT received FDA 510(k) clearance on 1984-04-03, under 510(k) number K834593.

Who is the listed applicant for ONE-PIECE SHUNT?

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

What is the FDA product code for ONE-PIECE SHUNT?

The FDA product code for ONE-PIECE SHUNT is JXG.

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Other records listing American Heyer Schulte as applicant

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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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