Cleared Traditional

TUBING PACK, EXTRACORPOREAL, H-3000 (K770720) - FDA 510(k) Clearance

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

K770720 · William Harvey Life Products Corp. · Cardiovascular device
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Aug 1977
Decision
108d
Days
Class 2
Risk

K770720 is an FDA 510(k) clearance for the TUBING PACK, EXTRACORPOREAL, H-3000. Classified as Oxygenator, Long Term Support Greater Than 6 Hours (product code BYS), Class II - Special Controls.

Submitted by William Harvey Life Products Corp. (Mchenry, US). The FDA issued a Cleared decision on August 4, 1977 after a review of 108 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4100 - 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 William Harvey Life Products Corp. devices

Submission Details

510(k) Number K770720 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 1977
Decision Date August 04, 1977
Days to Decision 108 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 125d · This submission: 108d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BYS Oxygenator, Long Term Support Greater Than 6 Hours
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4100
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.