Cleared Special

K012143 - 24 FR. LEFT HEART VENT CATHETER WITH PRESSURE MONITORING LINE, MODEL 12524

K012143 is an FDA 510(k) clearance for 24 FR. LEFT HEART VENT CATHETER WITH PR..., manufactured by Medtronic Cardiac Surgical Products. The device is a Class 2 Cardiovascular device with product code DRA cleared through the Special 510(k) pathway after a 106-day FDA review.

K012143 · Medtronic Cardiac Surgical Products · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2001
Decision
106d
Days
Class 2
Risk

K012143 is an FDA 510(k) clearance for the 24 FR. LEFT HEART VENT CATHETER WITH PRESSURE MONITORING LINE, MODEL 12524. Classified as Catheter, Steerable (product code DRA), Class II - Special Controls.

Submitted by Medtronic Cardiac Surgical Products (Grand Rapids, US). The FDA issued a Cleared decision on October 24, 2001 after a review of 106 days - within the typical 510(k) review window.

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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K012143

510(k) Number K012143 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 2001
Decision Date October 24, 2001
Days to Decision 106 days
Submission Type Special
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
19d faster than avg
Panel avg: 125d · This submission: 106d
Pathway characteristics
Modification to existing cleared device.

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 41
Devices cleared under the same product code (DRA) and FDA review panel - the closest regulatory comparables to K012143.
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CRI CYNOSAR CATHETER
K924227 · Catheter Research C/O Burditt, Bowles & Radzius · Jun 1993
RESPONSE(TM) STEERABLE CATHETER
K913940 · Daig Corp. · Jan 1993
CRI CYNOSAR CATHETER
K904785 · Catheter Research C/O Burditt, Bowles & Radzius · Mar 1991
K012143 · 24 FR. LEFT HEART VENT CATHETER WITH PRESSURE MONITORING LINE, MODEL 12524
Download PDF FDA Summary Medtronic Cardiac Sur…