High Dose Rate Remote Afterloading Catheter
FDA 510(k) K923738 · Cook, Inc.
510(k) numberK923738
Submission
- Device name
- High Dose Rate Remote Afterloading Catheter
- Applicant
- Cook, Inc.
Bloomington, IN, US - Received
- July 27, 1992
- Decision date
- April 13, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was High Dose Rate Remote Afterloading Catheter cleared by the FDA?
High Dose Rate Remote Afterloading Catheter (K923738) received a 510(k) decision of Substantially Equivalent on April 13, 1993, 260 days after the submission was received.
What is the product code of K923738?
The FDA product code is JAQ – System, Applicator, Radionuclide, Remote-Controlled, a Class II (moderate risk) device regulated under 21 CFR 892.5700.