Cleared Traditional

K971421 - BARD ISOFLOW BLOOD PUMP

K971421 is an FDA 510(k) clearance for BARD ISOFLOW BLOOD PUMP, manufactured by C.R. Bard, Inc.. The device is a Class 2 Cardiovascular device with product code DWA cleared through the Traditional 510(k) pathway after a 393-day FDA review.

K971421 · C.R. Bard, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1998
Decision
393d
Days
Class 2
Risk

K971421 is an FDA 510(k) clearance for the BARD ISOFLOW BLOOD PUMP. Classified as Control, Pump Speed, Cardiopulmonary Bypass (product code DWA), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Haverhill, US). The FDA issued a Cleared decision on May 14, 1998 after a review of 393 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4380 - 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. Elevated predicate reliance profile. 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 C.R. Bard, Inc. devices

FDA 510(k) Submission Details - K971421

510(k) Number K971421 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 1997
Decision Date May 14, 1998
Days to Decision 393 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
268d slower than avg
Panel avg: 125d · This submission: 393d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DWA Device Classification - Class 2, Special Controls

Product Code DWA Control, Pump Speed, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4380
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 - DWA Control, Pump Speed, Cardiopulmonary Bypass

All 19
Devices cleared under the same product code (DWA) and FDA review panel - the closest regulatory comparables to K971421.
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GAMBRO PULSATILE MONITOR PLM 10-200
K842503 · Gambro, Inc. · Aug 1984
MODEL 1812 CONTROL CONSOLE, ACCESSORIEX
K780952 · Medtronic Vascular · Aug 1978