Cleared Traditional

K864330 - SHEAR FORCE GAUGE

K864330 is an FDA 510(k) clearance for SHEAR FORCE GAUGE, manufactured by American Edwards Laboratories. The device is a Class 2 Cardiovascular device with product code DXE cleared through the Traditional 510(k) pathway after a 63-day FDA review.

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.

FDA 510(k) Submission Details - K864330

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
Combination Product No
PCCP Authorized No
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.

DXE Device Classification - Class 2, Special Controls

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.
EMBOLECTOMY CATHETER(MODIFIED)
K881455 · Cathlab Corp. · Jun 1988
CHANGE OF CATHETER BODY MATERIAL (RADIO-OPAQUE NY)
K872485 · Ideas For Medicine, Inc. · Aug 1987
PRUITT EMBOLECTOMY/IRRIGATION CATHETER (MODIFIED)
K864062 · Ideas For Medicine, Inc. · Jan 1987
EMBOLECTOMY/THROMBECTOMY BALLOON CATHETER
K864007 · Uresil Corp. · Jan 1987
NOVA ARTERIAL EMBOLECTOMY CATHETER
K853625 · Nova Medical Specialties · Jan 1986
POLYMED LAB ARTERIAL EMBOLECTOMY CATHETER
K850015 · Polymed Laboratories · Jun 1985
K864330 · SHEAR FORCE GAUGE
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