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FDA 510(k)

EPIX IRRIGATION PUMP, EPIX SUCTION IRRIGATION TUBING SET

K-Number: K122619 · 2012-10-02

ApplicantApplied Medical
Decision Date2012-10-02
Product CodeBTA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

EPIX IRRIGATION PUMP, EPIX SUCTION IRRIGATION TUBING SET is the device name listed in this FDA 510(k) record. The listed applicant is Applied Medical. It received FDA 510(k) clearance on 2012-10-02 under 510(k) number K122619. The device is classified under product code BTA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EPIX IRRIGATION PUMP, EPIX SUCTION IRRIGATION TUBING SET?

EPIX IRRIGATION PUMP, EPIX SUCTION IRRIGATION TUBING SET is a medical device that received FDA 510(k) clearance on 2012-10-02. The listed applicant is Applied Medical. The 510(k) number is K122619.

When did EPIX IRRIGATION PUMP, EPIX SUCTION IRRIGATION TUBING SET receive FDA 510(k) clearance?

EPIX IRRIGATION PUMP, EPIX SUCTION IRRIGATION TUBING SET received FDA 510(k) clearance on 2012-10-02, under 510(k) number K122619.

Who is the listed applicant for EPIX IRRIGATION PUMP, EPIX SUCTION IRRIGATION TUBING SET?

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

What is the FDA product code for EPIX IRRIGATION PUMP, EPIX SUCTION IRRIGATION TUBING SET?

The FDA product code for EPIX IRRIGATION PUMP, EPIX SUCTION IRRIGATION TUBING SET is BTA.

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Related Devices (Code: BTA)

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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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