Cleared Traditional

K183174 - FlexCath Advance Steerable Sheath and Dilator

K183174 is an FDA 510(k) clearance for FlexCath Advance Steerable Sheath and D..., manufactured by Medtronic Cryocath, LP. The device is a Class 2 Cardiovascular device with product code DRA cleared through the Traditional 510(k) pathway after a 10-day FDA review.

K183174 · Medtronic Cryocath, LP · Cardiovascular device
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Nov 2018
Decision
10d
Days
Class 2
Risk

K183174 is an FDA 510(k) clearance for the FlexCath Advance Steerable Sheath and Dilator. Classified as Catheter, Steerable (product code DRA), Class II - Special Controls.

Submitted by Medtronic Cryocath, LP (Minneapolis, US). The FDA issued a Cleared decision on November 26, 2018 after a review of 10 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 Medtronic Cryocath, LP devices

FDA 510(k) Submission Details - K183174

510(k) Number K183174 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 2018
Decision Date November 26, 2018
Days to Decision 10 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
115d faster than avg
Panel avg: 125d · This submission: 10d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRA Device Classification - Class 2, Special Controls

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 29
Devices cleared under the same product code (DRA) and FDA review panel - the closest regulatory comparables to K183174.
FlexCath Advance Steerable Sheath and Dilator
K202620 · Medtronic Cryocath, LP · Nov 2020
Steerable Introducer 12F
K192422 · Freudenberg Medical, LLC · Oct 2019
MitraClip G4 Steerable Guide Catheter
K190167 · Abbott · May 2019
Steerable Guide Catheter
K172394 · Abbott Vascular · Sep 2017
AcQGuide Steerable Sheath
K162925 · Acutus Medical, Inc. · Apr 2017
Hansen Medical Magellan Robotic Catheter 9Fr
K160919 · Hansen Medical, Inc. · Sep 2016