Cleared Traditional

K973475 - CARMEDA COATED CARDIOTHERM BLOOD CARDIO...

K973475 is the FDA 510(k) clearance for CARMEDA COATED CARDIOTHERM BLOOD CARDIO... by Medtronic Vascular. It is a Class 2 Cardiovascular device (product code DTR) cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K973475 · Medtronic Vascular · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Nov 1997
Decision
69d
Days
Class 2
Risk

K973475 is an FDA 510(k) clearance for the CARMEDA COATED CARDIOTHERM BLOOD CARDIOPLEGIA SYSTEMS (CBCTXXX SERIES AND CBC.... Classified as Heat-exchanger, Cardiopulmonary Bypass (product code DTR), Class II - Special Controls.

Submitted by Medtronic Vascular (Anaheim, US). The FDA issued a Cleared decision on November 20, 1997 after a review of 69 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Medtronic Vascular devices

Submission Details

510(k) Number K973475 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 1997
Decision Date November 20, 1997
Days to Decision 69 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
56d faster than avg
Panel avg: 125d · This submission: 69d
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 78
Devices cleared under the same product code (DTR) and FDA review panel - the closest regulatory comparables to K973475.
CBMYOTHERM XP CARDIOPLEGIA DELIVERY SYSTEM WITH CARMEDA BIOACTIVE SURFACE, MODELS CB41 AND CB41-B
K003724 · Medtronic Vascular · Dec 2000
ENGUARD PHX CARDIOPLEGIA HEAT EXCHANGER
K991137 · Minntech Corp. · Jun 2000
CAPIOX CARDIOPLEGIA
K982467 · Terumo Medical Corp. · Jun 1999
MYOCARDIAL PROTECTION SYSTEM
K953838 · Quest Medical, Inc. · Mar 1996
SINGLE PASS BLOOD CARDIOPLEGIA SPBC SYSTEM COMPONENTS
K944219 · Gish Biomedical, Inc. · Jun 1995
HEAT EXCHANGER MODIFICATION FOR DUO AND OPTIMA
K944267 · Cobe Cardiovascular, Inc. · Apr 1995