Cleared Traditional

K040355 - VISION BLOOD CARDIOPLEGIA SYSTEM AND EXTRACORPORAL HEAT EXCHANGER WITH GBS COATING

K040355 is an FDA 510(k) clearance for VISION BLOOD CARDIOPLEGIA SYSTEM AND EX..., manufactured by Gish Biomedical, Inc.. The device is a Class 2 Cardiovascular device with product code DTR cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K040355 · Gish Biomedical, Inc. · Cardiovascular device
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Mar 2004
Decision
32d
Days
Class 2
Risk

K040355 is an FDA 510(k) clearance for the VISION BLOOD CARDIOPLEGIA SYSTEM AND EXTRACORPORAL HEAT EXCHANGER WITH GBS CO.... Classified as Heat-exchanger, Cardiopulmonary Bypass (product code DTR), Class II - Special Controls.

Submitted by Gish Biomedical, Inc. (Houston, US). The FDA issued a Cleared decision on March 15, 2004 after a review of 32 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 Gish Biomedical, Inc. devices

FDA 510(k) Submission Details - K040355

510(k) Number K040355 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 2004
Decision Date March 15, 2004
Days to Decision 32 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
93d faster than avg
Panel avg: 125d · This submission: 32d
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 85
Devices cleared under the same product code (DTR) and FDA review panel - the closest regulatory comparables to K040355.
GISH VISION BLOOD CARDIOPLEGIA WITH HA COATING
K081838 · Gish Biomedical, Inc. · Jan 2009
PLEGIOX CARDIOPLEGIA HEAT EXCHANGER, WITH SAFELINE COATING, MODEL(S) CHX30, BSQ-CHX 30
K072583 · Maquet Cardiopulmonary, AG · Apr 2008
MPS MYOCARDIAL PROTECTION SYSTEM - MPS 2 CONSOLE, MODEL 5201260
K041979 · Quest Medical, Inc. · Sep 2004
SORIN BIOMEDICA SMARXT BCD VANGUARD SURFACE MODIFIED CARDIOPLEGIA SYSTEM
K021830 · Cobe Cardiovascular, Inc. · Jul 2002
VISION BLOOD CARDIOPLEGIA SYSTEM AND EXTRACORPOREAL HEAT EXCHANGER
K020106 · Gish Biomedical, Inc. · Apr 2002
MODIFICATION TO: CSC14 BLOOD CARDIOPLEGIA SYSTEM
K012898 · Cobe Cardiovascular, Inc. · Sep 2001