Cleared Traditional

K012325 - CARDIOVENTION CORX SYSTEM, MODEL FG 0001

K012325 is an FDA 510(k) clearance for CARDIOVENTION CORX SYSTEM, manufactured by Cardiovention, Inc.. The device is a Class 2 Cardiovascular device with product code KFM cleared through the Traditional 510(k) pathway after a 260-day FDA review.

K012325 · Cardiovention, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2002
Decision
260d
Days
Class 2
Risk

K012325 is an FDA 510(k) clearance for the CARDIOVENTION CORX SYSTEM, MODEL FG 0001. Classified as Pump, Blood, Cardiopulmonary Bypass, Non-roller Type (product code KFM), Class II - Special Controls.

Submitted by Cardiovention, Inc. (Santa Clara, US). The FDA issued a Cleared decision on April 9, 2002 after a review of 260 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4360 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Cardiovention, Inc. devices

FDA 510(k) Submission Details - K012325

510(k) Number K012325 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 2001
Decision Date April 09, 2002
Days to Decision 260 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
135d slower than avg
Panel avg: 125d · This submission: 260d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KFM Device Classification - Class 2, Special Controls

Product Code KFM Pump, Blood, Cardiopulmonary Bypass, Non-roller Type
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4360
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 - KFM Pump, Blood, Cardiopulmonary Bypass, Non-roller Type

All 71
Devices cleared under the same product code (KFM) and FDA review panel - the closest regulatory comparables to K012325.
IBC FLOPUMP WITH GBS COATING
K031300 · Gish Biomedical, Inc. · May 2003
IDEAL: SYSTEM WITH INTEGRATED VENOUS AIR REMOVAL, CENTRIFUGAL BLOOD PUMP, PUMP BRACKET, ADULT MEMBRANE OXYGENATOR
K030154 · Dideco S.P.A. · Mar 2003
COBE REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC, MODEL 050300700
K030462 · Cobe Cardiovascular, Inc. · Mar 2003
SARNS CENTRIFUGAL PUMP WITH XCOATING, MODEL 164275X
K020998 · Terumo Cardiovascular Systems Corp. · Apr 2002
COBE REVOLUTION
K011835 · Cobe Cardiovascular, Inc. · Feb 2002
CAPIOX SP PUMP WITH X-COATING PRODUCT CODE: CXSP45X
K012209 · Terumo Cardiovascular Systems Corp. · Aug 2001