Cleared Traditional

K792088 - AORTIC OCCLUDER #000390

K792088 is an FDA 510(k) clearance for AORTIC OCCLUDER #000390, manufactured by Edward Weck, Inc.. The device is a Class 1 Cardiovascular device with product code DWS cleared through the Traditional 510(k) pathway after a 9-day FDA review.

K792088 · Edward Weck, Inc. · Cardiovascular device
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Oct 1979
Decision
9d
Days
Class 1
Risk

K792088 is an FDA 510(k) clearance for the AORTIC OCCLUDER #000390. Classified as Instruments, Surgical, Cardiovascular (product code DWS), Class I - General Controls.

Submitted by Edward Weck, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 26, 1979 after a review of 9 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 Edward Weck, Inc. devices

FDA 510(k) Submission Details - K792088

510(k) Number K792088 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 1979
Decision Date October 26, 1979
Days to Decision 9 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
116d faster than avg
Panel avg: 125d · This submission: 9d
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 39
Devices cleared under the same product code (DWS) and FDA review panel - the closest regulatory comparables to K792088.
DEKNATEL GOOSEN VASCULAR PUNCH BLADES
K802079 · Howmedica Corp. · Sep 1980
AIR ASPIRATOR NEEDLE
K801393 · Texas Medical Products, Inc. · Jun 1980
CASTROVIEJO VASCULAR SCISSORS
K792576 · Edward Weck, Inc. · Dec 1979
CARDIOVASCULAR INSTRUMENTS-VARIOUS
K791710 · Edward Weck, Inc. · Sep 1979
SILICONE SURGICAL VESSEL LOOPS
K791370 · Conphar, Inc. · Aug 1979
GRAFT TUNNELER
K790124 · Narco Scientific · Feb 1979