Cleared Special

FLEXCATH ADVANCE STEERABLE SHEATH (12 FRENCH) (K123591) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K123591 · Medtronic Cryocath, LP · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2012
Decision
36d
Days
Class 2
Risk

K123591 is an FDA 510(k) clearance for the FLEXCATH ADVANCE STEERABLE SHEATH (12 FRENCH). Classified as Catheter, Steerable (product code DRA), Class II - Special Controls.

Submitted by Medtronic Cryocath, LP (Mounds View, US). The FDA issued a Cleared decision on December 27, 2012 after a review of 36 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Medtronic Cryocath, LP devices

Submission Details

510(k) Number K123591 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 2012
Decision Date December 27, 2012
Days to Decision 36 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
89d faster than avg
Panel avg: 125d · This submission: 36d
Pathway characteristics
Modification to existing cleared device.

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 K123591.
Globe Introducer (601-01001)
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