Adjustable Multi-Catheter Source Applictor

FDA 510(k) K062241 · North American Scientific, Inc.

Unknown

510(k) numberK062241

Submission

Device name
Adjustable Multi-Catheter Source Applictor
Applicant
North American Scientific, Inc.
Chatsworth, CA, US
Received
August 2, 2006
Decision date
November 9, 2006
Decision
Unknown (SESU)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
JAQ – System, Applicator, Radionuclide, Remote-Controlled
Device class
Class II (moderate risk)
Regulation
21 CFR 892.5700
Specialty
Radiology

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Questions and answers

When was Adjustable Multi-Catheter Source Applictor cleared by the FDA?

Adjustable Multi-Catheter Source Applictor (K062241) received a 510(k) decision of Unknown on November 9, 2006, 99 days after the submission was received.

What is the product code of K062241?

The FDA product code is JAQ – System, Applicator, Radionuclide, Remote-Controlled, a Class II (moderate risk) device regulated under 21 CFR 892.5700.