Cleared Traditional

ENGUARD PHX CARDIOPLEGIA HEAT EXCHANGER (K991137) - FDA 510(k) Clearance

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

K991137 · Minntech Corp. · Cardiovascular device
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Jun 2000
Decision
430d
Days
Class 2
Risk

K991137 is an FDA 510(k) clearance for the ENGUARD PHX CARDIOPLEGIA HEAT EXCHANGER. Classified as Heat-exchanger, Cardiopulmonary Bypass (product code DTR), Class II - Special Controls.

Submitted by Minntech Corp. (Minneapolis, US). The FDA issued a Cleared decision on June 8, 2000 after a review of 430 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4240 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all Minntech Corp. devices

Submission Details

510(k) Number K991137 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 1999
Decision Date June 08, 2000
Days to Decision 430 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
305d slower than avg
Panel avg: 125d · This submission: 430d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DTR Heat-exchanger, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4240
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 - DTR Heat-exchanger, Cardiopulmonary Bypass

All 90
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