Cleared Traditional

K192422 - Steerable Introducer 12F (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
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 Peers - DRA Catheter, Steerable

All 40
Devices cleared under the same product code (DRA) and FDA review panel - the closest regulatory comparables to K192422.
Globe Introducer (601-01001)
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K221044 · Acutus Medical, Inc. · May 2022