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FDA 510(k)

UNICATH SP BI-PLANE (MODEL M269 & M289)

K-Number: K973744 · 1997-12-29

ApplicantXre Corp.
Decision Date1997-12-29
Product CodeJAA
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

UNICATH SP BI-PLANE (MODEL M269 & M289) is the device name listed in this FDA 510(k) record. The listed applicant is Xre Corp.. It received FDA 510(k) clearance on 1997-12-29 under 510(k) number K973744. The device is classified under product code JAA. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UNICATH SP BI-PLANE (MODEL M269 & M289)?

UNICATH SP BI-PLANE (MODEL M269 & M289) is a medical device that received FDA 510(k) clearance on 1997-12-29. The listed applicant is Xre Corp.. The 510(k) number is K973744.

When did UNICATH SP BI-PLANE (MODEL M269 & M289) receive FDA 510(k) clearance?

UNICATH SP BI-PLANE (MODEL M269 & M289) received FDA 510(k) clearance on 1997-12-29, under 510(k) number K973744.

Who is the listed applicant for UNICATH SP BI-PLANE (MODEL M269 & M289)?

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

What is the FDA product code for UNICATH SP BI-PLANE (MODEL M269 & M289)?

The FDA product code for UNICATH SP BI-PLANE (MODEL M269 & M289) is JAA.

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Related Devices (Code: JAA)

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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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