Cleared Traditional

K040355 - VISION BLOOD CARDIOPLEGIA SYSTEM AND EX...

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 82
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