Cleared Traditional

Steerable Introducer 12F (K192422) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K192422 · Freudenberg Medical, LLC · Cardiovascular device
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Oct 2019
Decision
30d
Days
Class 2
Risk

K192422 is an FDA 510(k) clearance for the Steerable Introducer 12F. Classified as Catheter, Steerable (product code DRA), Class II - Special Controls.

Submitted by Freudenberg Medical, LLC (Jeffersonville, US). The FDA issued a Cleared decision on October 4, 2019 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1280 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Freudenberg Medical, LLC devices

Submission Details

510(k) Number K192422 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 2019
Decision Date October 04, 2019
Days to Decision 30 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 125d · This submission: 30d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

Product Code DRA Catheter, Steerable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1280
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Consultant

Regulatory Technology Services, LLC
Prithul Bom

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - DRA Catheter, Steerable

All 10
Devices cleared under the same product code (DRA) and FDA review panel - the closest regulatory comparables to K192422.
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AcQGuide MAX Steerable Sheath
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FlexCath Advance Steerable Sheath and Dilator
K202620 · Medtronic Cryocath, LP · Nov 2020
MitraClip G4 Steerable Guide Catheter
K190167 · Abbott · May 2019
FlexCath Advance Steerable Sheath and Dilator
K183174 · Medtronic Cryocath, LP · Nov 2018