Mongoose Angiographic Catheter

FDA 510(k) K113819 · Pediacath, Inc.

Substantially Equivalent

510(k) numberK113819

Submission

Device name
Mongoose Angiographic Catheter
Applicant
Pediacath, Inc.
Austin, TX, US
Received
December 27, 2011
Decision date
July 11, 2012
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
DQO – Catheter, Intravascular, Diagnostic
Device class
Class II (moderate risk)
Regulation
21 CFR 870.1200
Specialty
Cardiovascular

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Questions and answers

When was Mongoose Angiographic Catheter cleared by the FDA?

Mongoose Angiographic Catheter (K113819) received a 510(k) decision of Substantially Equivalent on July 11, 2012, 197 days after the submission was received.

What is the product code of K113819?

The FDA product code is DQO – Catheter, Intravascular, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 870.1200.