Cleared Traditional

BARD ISOFLOW BLOOD PUMP (K971421) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K971421 · C.R. Bard, Inc. · Cardiovascular device
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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

Submission Details

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.

Device Classification

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 36
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