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FDA 510(k)

Certas Plus Programmable Valves

K-Number: K223330 · 2023-02-01

ApplicantIntegra Lifesciences Production Corporation
Decision Date2023-02-01
Product CodeJXG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Certas Plus Programmable 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 2023-02-01 under 510(k) number K223330. 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 Certas Plus Programmable Valves?

Certas Plus Programmable Valves is a medical device that received FDA 510(k) clearance on 2023-02-01. The listed applicant is Integra Lifesciences Production Corporation. The 510(k) number is K223330.

When did Certas Plus Programmable Valves receive FDA 510(k) clearance?

Certas Plus Programmable Valves received FDA 510(k) clearance on 2023-02-01, under 510(k) number K223330.

Who is the listed applicant for Certas Plus Programmable 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 Certas Plus Programmable Valves?

The FDA product code for Certas Plus Programmable Valves is JXG.

Other records listing Integra Lifesciences Production Corporation as applicant

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Related Devices (Code: JXG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261004Codman® Distal Peritoneal Catheter, Barium Open End (82-1682); Codman® HOLTER® Peritoneal Catheter (SALMON Design) (82-1684)Integra Lifesciences Production CorporationK251598IntellidropBrainspace, Inc.K250636Sophy Mini Monopressure Valve (SM1)SophysaK252514EVAC-MRIPhasor Health, LLCK243531Codman Libertís Shunt Catheter with Bactiseal and Endexo TechnologyIntegra Lifesciences Production CorporationK243552Codman Libertís™ 1.5 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer Connection (821761); Codman Libertís™ 1.9 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer Connection (821762)Integra Lifesciences Production Corporation

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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