Steerable Introducer 12F
K-Number: K192422 · 2019-10-04
Device Summary
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. The listed applicant is Freudenberg Medical, LLC. The 510(k) number is K192422.
When did Steerable Introducer 12F receive FDA 510(k) clearance?
Steerable Introducer 12F received FDA 510(k) clearance on 2019-10-04, under 510(k) number K192422.
Who is the listed applicant for Steerable Introducer 12F?
The FDA 510(k) record lists Freudenberg Medical, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Steerable Introducer 12F?
The FDA product code for Steerable Introducer 12F is DRA.
Other records listing Freudenberg Medical, LLC as applicant
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Related Devices (Code: DRA)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
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.