Steerable Introducer 12F
K-Number: K192422 · 2019-10-04
ApplicantFreudenberg Medical, LLC
Decision Date2019-10-04
Product CodeDRA
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Steerable Introducer 12F is a medical device manufactured by Freudenberg Medical, LLC. It received FDA 510(k) clearance on 2019-10-04 under approval number K192422. The device is classified under product code DRA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Steerable Introducer 12F?
Steerable Introducer 12F is a medical device that received FDA 510(k) clearance on 2019-10-04. It is manufactured by Freudenberg Medical, LLC. The 510(k) number is K192422.
When was Steerable Introducer 12F approved by the FDA?
Steerable Introducer 12F received FDA 510(k) clearance on 2019-10-04, under approval number K192422.
What company makes Steerable Introducer 12F?
Steerable Introducer 12F is manufactured by Freudenberg Medical, LLC.
What is the FDA product code for Steerable Introducer 12F?
The FDA product code for Steerable Introducer 12F is DRA.
Related Clinical Trials
Other Devices by Freudenberg Medical, LLC
Related Devices (Code: DRA)
K160919Hansen Medical Magellan Robotic Catheter 9FrHansen Medical, Inc.
K161985Steerable Guide CatheterAbbott Vascular
K152310HeartLight Deflectable SheathCardiofocus, Inc.
K153304Hansen Medical Magellan Robotic Catheter eKitHansen Medical, Inc.
K172394Steerable Guide CatheterAbbott Vascular
K162925AcQGuide Steerable SheathAcutus Medical, Inc.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.