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FDA 510(k)

GRAC HIGH DOSE RATE (HDR) REMOTE AFTERLOADING CATHETER

K-Number: K990753 · 1999-05-27

ApplicantCook, Inc.
Decision Date1999-05-27
Product CodeJAQ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

GRAC HIGH DOSE RATE (HDR) REMOTE AFTERLOADING CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Cook, Inc.. It received FDA 510(k) clearance on 1999-05-27 under 510(k) number K990753. The device is classified under product code JAQ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GRAC HIGH DOSE RATE (HDR) REMOTE AFTERLOADING CATHETER?

GRAC HIGH DOSE RATE (HDR) REMOTE AFTERLOADING CATHETER is a medical device that received FDA 510(k) clearance on 1999-05-27. The listed applicant is Cook, Inc.. The 510(k) number is K990753.

When did GRAC HIGH DOSE RATE (HDR) REMOTE AFTERLOADING CATHETER receive FDA 510(k) clearance?

GRAC HIGH DOSE RATE (HDR) REMOTE AFTERLOADING CATHETER received FDA 510(k) clearance on 1999-05-27, under 510(k) number K990753.

Who is the listed applicant for GRAC HIGH DOSE RATE (HDR) REMOTE AFTERLOADING CATHETER?

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

What is the FDA product code for GRAC HIGH DOSE RATE (HDR) REMOTE AFTERLOADING CATHETER?

The FDA product code for GRAC HIGH DOSE RATE (HDR) REMOTE AFTERLOADING CATHETER is JAQ.

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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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