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FDA 510(k)

OPTYX

K-Number: K904883 · 1991-07-24

ApplicantBaxter Healthcare Corp
Decision Date1991-07-24
Product CodeJXG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

OPTYX is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Healthcare Corp. It received FDA 510(k) clearance on 1991-07-24 under 510(k) number K904883. 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 OPTYX?

OPTYX is a medical device that received FDA 510(k) clearance on 1991-07-24. The listed applicant is Baxter Healthcare Corp. The 510(k) number is K904883.

When did OPTYX receive FDA 510(k) clearance?

OPTYX received FDA 510(k) clearance on 1991-07-24, under 510(k) number K904883.

Who is the listed applicant for OPTYX?

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

What is the FDA product code for OPTYX?

The FDA product code for OPTYX is JXG.

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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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