Cleared Traditional

K832417 - HYPOTHERMIC MYCARDIAL PROTECTION DEV

K832417 is an FDA 510(k) clearance for HYPOTHERMIC MYCARDIAL PROTECTION DEV, manufactured by 3M Health Care, Sarns. The device is a Class 2 Cardiovascular device with product code DTR cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K832417 · 3M Health Care, Sarns · Cardiovascular device
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Oct 1983
Decision
91d
Days
Class 2
Risk

K832417 is an FDA 510(k) clearance for the HYPOTHERMIC MYCARDIAL PROTECTION DEV. Classified as Heat-exchanger, Cardiopulmonary Bypass (product code DTR), Class II - Special Controls.

Submitted by 3M Health Care, Sarns (Mchenry, US). The FDA issued a Cleared decision on October 20, 1983 after a review of 91 days - within the typical 510(k) review window.

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: 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 3M Health Care, Sarns devices

FDA 510(k) Submission Details - K832417

510(k) Number K832417 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 1983
Decision Date October 20, 1983
Days to Decision 91 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
34d faster than avg
Panel avg: 125d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DTR Device Classification - Class 2, Special Controls

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 84
Devices cleared under the same product code (DTR) and FDA review panel - the closest regulatory comparables to K832417.
CARDIOPLEGIA HEAT EXCHANGER HE-100
K840045 · American Bentley · Feb 1984
LAL TEST RELEASE & BONCHEK CAR/JACKET
K833555 · Shiley, Inc. · Feb 1984
CARDIOPLEGIA SYSTEM CCS-XXX SERIES
K833662 · Gish Biomedical, Inc. · Dec 1983
BLOOD CARDIOPLEGIA STAINLESS STEEL COOL
K831157 · American Bentley · May 1983
CLEAR CARDIOPLEJIA DELIVERY SYSTEM
K823451 · 3M Health Care, Sarns · Jan 1983
JACKET & SET
K823533 · Shiley, Inc. · Dec 1982