Cleared Traditional

K183174 - FlexCath Advance Steerable Sheath and D...

K183174 is the FDA 510(k) clearance for FlexCath Advance Steerable Sheath and D... by Medtronic Cryocath, LP. It is a Class 2 Cardiovascular device (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

Submission Details

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.

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 15
Devices cleared under the same product code (DRA) and FDA review panel - the closest regulatory comparables to K183174.
FlexCath Advance Steerable Sheath and Dilator
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K052575 · St Jude Medical · Jan 2006
REFLEXION CANNULATOR STEERABLE ELECTROPHYSIOLOGY CATHETER WITH LUMEN, MODEL 402805
K040165 · St Jude Medical · May 2004
RESPONSE(TM) STEERABLE CATHETER
K913940 · Daig Corp. · Jan 1993