Colab Cocath(Tm) Implanted Catheter and Depot

FDA 510(k) K896197 · Colab Intl., Inc.

Substantially Equivalent

510(k) numberK896197

Submission

Device name
Colab Cocath(Tm) Implanted Catheter and Depot
Applicant
Colab Intl., Inc.
New Orleans, LA, US
Received
October 27, 1989
Decision date
July 11, 1990
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
KXK – Source, Brachytherapy, Radionuclide
Device class
Class II (moderate risk)
Regulation
21 CFR 892.5730
Specialty
Radiology
Implant
Yes

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Questions and answers

When was Colab Cocath(Tm) Implanted Catheter and Depot cleared by the FDA?

Colab Cocath(Tm) Implanted Catheter and Depot (K896197) received a 510(k) decision of Substantially Equivalent on July 11, 1990, 257 days after the submission was received.

What is the product code of K896197?

The FDA product code is KXK – Source, Brachytherapy, Radionuclide, a Class II (moderate risk) device regulated under 21 CFR 892.5730.