Hereaeus Poseidon Microcatheter

FDA 510(k) K191305 · Heraeus Medical Components, LLC

Substantially Equivalent

510(k) numberK191305

Submission

Device name
Hereaeus Poseidon Microcatheter
Applicant
Heraeus Medical Components, LLC
Plymouth, MN, US
Received
May 14, 2019
Decision date
December 19, 2019
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
KRA – Catheter, Continuous Flush
Device class
Class II (moderate risk)
Regulation
21 CFR 870.1210
Specialty
Cardiovascular

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Questions and answers

When was Hereaeus Poseidon Microcatheter cleared by the FDA?

Hereaeus Poseidon Microcatheter (K191305) received a 510(k) decision of Substantially Equivalent on December 19, 2019, 219 days after the submission was received.

What is the product code of K191305?

The FDA product code is KRA – Catheter, Continuous Flush, a Class II (moderate risk) device regulated under 21 CFR 870.1210.