Cleared Traditional

HYPOTHERMIC MYCARDIAL PROTECTION DEV (K832417) - FDA 510(k) Clearance

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

K832417 · 3M Health Care, Sarns · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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
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.

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 32
Devices cleared under the same product code (DTR) and FDA review panel - the closest regulatory comparables to K832417.
MODEL 492-03 POLYFLEX IMPLANTABLE PACING LEAD
K853410 · Intermedics, Inc. · Oct 1985
BCD PLUS BLOOD CARDIOPLEGIA SYS(HEREAF REFER DEV)
K852780 · Shiley, Inc. · Sep 1985
LAL TEST RELEASE & BONCHEK CAR/JACKET
K833555 · Shiley, Inc. · Feb 1984
JACKET & SET
K823533 · Shiley, Inc. · Dec 1982
BRONCHEK-SHILEY CARDIAC JACKET & BSC J
K811204 · Shiley, Inc. · May 1981
BUCKBERG-SHILEY BLOOD CARDIOPLEGIC SPL.
K802879 · Shiley, Inc. · Dec 1980