Cleared Traditional

K761328 - ANASTOMASIS OCCLUDER (FDA 510(k) Clearance)

Class I Cardiovascular device.

K761328 · Medical Engineering Corp. · Cardiovascular device
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Feb 1977
Decision
36d
Days
Class 1
Risk

K761328 is an FDA 510(k) clearance for the ANASTOMASIS OCCLUDER. Classified as Instruments, Surgical, Cardiovascular (product code DWS), Class I - General Controls.

Submitted by Medical Engineering Corp. (Mchenry, US). The FDA issued a Cleared decision on February 1, 1977 after a review of 36 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4500 - 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 Medical Engineering Corp. devices

Submission Details

510(k) Number K761328 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 1976
Decision Date February 01, 1977
Days to Decision 36 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
89d faster than avg
Panel avg: 125d · This submission: 36d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DWS Instruments, Surgical, Cardiovascular
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 870.4500
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.