Cleared Traditional

K823094 - CARDIAC ELEVATOR

K823094 is an FDA 510(k) clearance for CARDIAC ELEVATOR, manufactured by Cardio Surgical Research, Inc.. The device is a Class 1 Cardiovascular device with product code DWS cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K823094 · Cardio Surgical Research, Inc. · Cardiovascular device
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Dec 1982
Decision
56d
Days
Class 1
Risk

K823094 is an FDA 510(k) clearance for the CARDIAC ELEVATOR. Classified as Instruments, Surgical, Cardiovascular (product code DWS), Class I - General Controls.

Submitted by Cardio Surgical Research, Inc. (Walker, US). The FDA issued a Cleared decision on December 15, 1982 after a review of 56 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 Cardio Surgical Research, Inc. devices

FDA 510(k) Submission Details - K823094

510(k) Number K823094 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 1982
Decision Date December 15, 1982
Days to Decision 56 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 125d · This submission: 56d
Pathway characteristics
Predicate-based equivalence.

DWS Device Classification - Class 1, General Controls

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.

Regulatory Peers - DWS Instruments, Surgical, Cardiovascular

All 54
Devices cleared under the same product code (DWS) and FDA review panel - the closest regulatory comparables to K823094.
CATEGORY 1 CIRCULATORY SYSTEM DEVICE
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LEATHER VALVULOTOME
K821569 · American V. Mueller · May 1982
DEKNATEL DISPOSABLE GOOSEN VASCULAR PNCH
K820258 · Howmedica Corp. · Mar 1982
DEKNATEL GOOSEN VASCULAR PUNCH BLADES
K802079 · Howmedica Corp. · Sep 1980