Cleared Traditional

K973237 - CSS-CARDIOPLEGIA SAFETY SYSTEM

K973237 is an FDA 510(k) clearance for CSS-CARDIOPLEGIA SAFETY SYSTEM, manufactured by Medtronic Bio-Medicus, Inc.. The device is a Class 2 Cardiovascular device with product code DWB cleared through the Traditional 510(k) pathway after a 242-day FDA review.

K973237 · Medtronic Bio-Medicus, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1998
Decision
242d
Days
Class 2
Risk

K973237 is an FDA 510(k) clearance for the CSS-CARDIOPLEGIA SAFETY SYSTEM. Classified as Pump, Blood, Cardiopulmonary Bypass, Roller Type (product code DWB), Class II - Special Controls.

Submitted by Medtronic Bio-Medicus, Inc. (Eden Prairie, US). The FDA issued a Cleared decision on April 27, 1998 after a review of 242 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4370 - 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 Medtronic Bio-Medicus, Inc. devices

FDA 510(k) Submission Details - K973237

510(k) Number K973237 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 1997
Decision Date April 27, 1998
Days to Decision 242 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
117d slower than avg
Panel avg: 125d · This submission: 242d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DWB Device Classification - Class 2, Special Controls

Product Code DWB Pump, Blood, Cardiopulmonary Bypass, Roller Type
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4370
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 - DWB Pump, Blood, Cardiopulmonary Bypass, Roller Type

All 18
Devices cleared under the same product code (DWB) and FDA review panel - the closest regulatory comparables to K973237.
Small (4) Roller Pump for the Terumo Advanced Perfusion System 1, Large (6) Roller Pump for the Terumo Advanced Perfusion System 1
K162843 · Terumo Cardiovascular Systems Corporation · Nov 2016
LARGE (6) ROLLER PUMP FOR TERUMO ADVANCED PERFUSION SYSTEM 1
K131618 · Terumo Cardiovascular Systems Corporation · Sep 2013
ADVANCED PERFUSION SYSTEM 1 (APS1) TUBE CLAMP ASSEMBLY, ROLLER PUMP 6 INCH CLASSIC COLOR,
K112587 · Terumo Cardiovascular Systems Corp. · Dec 2011
S3 MAST PUMP
K972321 · Stoeckert Instrumente · Feb 1998
S3 CYCLIC RPM CONTROL
K971520 · Stoeckert Instrumente · Sep 1997
COBE CENTURY PERFUSION PUMP
K960974 · Cobe Cardiovascular, Inc. · Jul 1997