Cleared Traditional

K893207 - CLOSED CHEST SUPPORT CIRCUIT

K893207 is the FDA 510(k) clearance for CLOSED CHEST SUPPORT CIRCUIT by Medtronic Blood Systems, Inc.. It is a Class 2 Cardiovascular device (product code DTZ) cleared through the Traditional 510(k) pathway after a 230-day FDA review.

K893207 · Medtronic Blood Systems, Inc. · Cardiovascular device
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Dec 1989
Decision
230d
Days
Class 2
Risk

K893207 is an FDA 510(k) clearance for the CLOSED CHEST SUPPORT CIRCUIT. Classified as Oxygenator, Cardiopulmonary Bypass (product code DTZ), Class II - Special Controls.

Submitted by Medtronic Blood Systems, Inc. (Anaheim, US). The FDA issued a Cleared decision on December 12, 1989 after a review of 230 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4350 - 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 Medtronic Blood Systems, Inc. devices

Submission Details

510(k) Number K893207 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 1989
Decision Date December 12, 1989
Days to Decision 230 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
105d slower than avg
Panel avg: 125d · This submission: 230d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DTZ Oxygenator, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4350
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 - DTZ Oxygenator, Cardiopulmonary Bypass

All 192
Devices cleared under the same product code (DTZ) and FDA review panel - the closest regulatory comparables to K893207.
UNIVOX W/HOLDERS, MODELS UNIVOX-HL, HLB, HLF
K894826 · Bentley Laboratories, Inc. · Feb 1990
CLOSED CHEST SUPPORT CIRCUIT W/BIO-ACTIVE SURFACE
K896978 · Medtronic Vascular · Feb 1990
SARNS MEMBRANE OXYGENATOR W/INTEGRAL RESER. #9461
K896671 · 3M Company · Feb 1990
SARNS MEMBRANE OXYGENATOR W/INTEGRAL CADIO. 16380
K895632 · 3M Company · Dec 1989
SARNS INGANT MEMBRANE OXYGENATOR
K895393 · 3M Company · Dec 1989
SHILEY PLEXUS(TM) ADULT HOLLOW FIBER OXYGENATOR
K894630 · Shiley, Inc. · Oct 1989