Occlusion Perfusion Catheter

FDA 510(k) K130525 · Advanced Catheter Therapies, Inc.

Substantially Equivalent

510(k) numberK130525

Submission

Device name
Occlusion Perfusion Catheter
Applicant
Advanced Catheter Therapies, Inc.
Kenosha, WI, US
Received
February 28, 2013
Decision date
October 3, 2013
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
DQY – Catheter, Percutaneous
Device class
Class II (moderate risk)
Regulation
21 CFR 870.1250
Specialty
Cardiovascular

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Questions and answers

When was Occlusion Perfusion Catheter cleared by the FDA?

Occlusion Perfusion Catheter (K130525) received a 510(k) decision of Substantially Equivalent on October 3, 2013, 217 days after the submission was received.

What is the product code of K130525?

The FDA product code is DQY – Catheter, Percutaneous, a Class II (moderate risk) device regulated under 21 CFR 870.1250.