Odyssey Micro Catheter

FDA 510(k) K170664 · Heraeus Medical Components, LLC

Substantially Equivalent

510(k) numberK170664

Submission

Device name
Odyssey Micro Catheter
Applicant
Heraeus Medical Components, LLC
Plymouth, MN, US
Received
March 6, 2017
Decision date
November 9, 2017
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary 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 Odyssey Micro Catheter cleared by the FDA?

Odyssey Micro Catheter (K170664) received a 510(k) decision of Substantially Equivalent on November 9, 2017, 248 days after the submission was received.

What is the product code of K170664?

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