Steerable Introducer

FDA 510(k) K191190 · Freudenberg Medical, LLC

Substantially Equivalent

510(k) numberK191190

Submission

Device name
Steerable Introducer
Applicant
Freudenberg Medical, LLC
Jeffersonville, IN, US
Received
May 3, 2019
Decision date
August 1, 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
DYB – Introducer, Catheter
Device class
Class II (moderate risk)
Regulation
21 CFR 870.1340
Specialty
Cardiovascular

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Questions and answers

When was Steerable Introducer cleared by the FDA?

Steerable Introducer (K191190) received a 510(k) decision of Substantially Equivalent on August 1, 2019, 90 days after the submission was received.

What is the product code of K191190?

The FDA product code is DYB – Introducer, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1340.