FDA 510(k)

Hakim Programmable Valves, Hakim Precision Fixed Pressure Valves

K-Number: K221840 · 2022-10-14

ApplicantIntegra Lifesciences Production Corporation

Decision Date2022-10-14

Product CodeJXG

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

Hakim Programmable Valves, Hakim Precision Fixed Pressure Valves is the device name listed in this FDA 510(k) record. The listed applicant is Integra Lifesciences Production Corporation. It received FDA 510(k) clearance on 2022-10-14 under 510(k) number K221840. 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 Hakim Programmable Valves, Hakim Precision Fixed Pressure Valves?

Hakim Programmable Valves, Hakim Precision Fixed Pressure Valves is a medical device that received FDA 510(k) clearance on 2022-10-14. The listed applicant is Integra Lifesciences Production Corporation. The 510(k) number is K221840.

When did Hakim Programmable Valves, Hakim Precision Fixed Pressure Valves receive FDA 510(k) clearance?

Hakim Programmable Valves, Hakim Precision Fixed Pressure Valves received FDA 510(k) clearance on 2022-10-14, under 510(k) number K221840.

Who is the listed applicant for Hakim Programmable Valves, Hakim Precision Fixed Pressure Valves?

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

What is the FDA product code for Hakim Programmable Valves, Hakim Precision Fixed Pressure Valves?

The FDA product code for Hakim Programmable Valves, Hakim Precision Fixed Pressure Valves is JXG.

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Related Devices (Code: JXG)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.