Cleared Traditional

K864330 - SHEAR FORCE GAUGE (FDA 510(k) Clearance)

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

K864330 · American Edwards Laboratories · Cardiovascular device
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Jan 1987
Decision
63d
Days
Class 2
Risk

K864330 is an FDA 510(k) clearance for the SHEAR FORCE GAUGE. Classified as Catheter, Embolectomy (product code DXE), Class II - Special Controls.

Submitted by American Edwards Laboratories (Santa Ana, US). The FDA issued a Cleared decision on January 6, 1987 after a review of 63 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5150 - 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.

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Submission Details

510(k) Number K864330 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 1986
Decision Date January 06, 1987
Days to Decision 63 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 125d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DXE Catheter, Embolectomy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5150
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 - DXE Catheter, Embolectomy

All 73
Devices cleared under the same product code (DXE) and FDA review panel - the closest regulatory comparables to K864330.
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