Cleared Traditional

K780567 - AORTIC PUMP

K780567 is an FDA 510(k) clearance for AORTIC PUMP, manufactured by Ethicon, Inc.. The device is a Class 1 Cardiovascular device with product code DWS cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K780567 · Ethicon, Inc. · Cardiovascular device
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Apr 1978
Decision
22d
Days
Class 1
Risk

K780567 is an FDA 510(k) clearance for the AORTIC PUMP. Classified as Instruments, Surgical, Cardiovascular (product code DWS), Class I - General Controls.

Submitted by Ethicon, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 28, 1978 after a review of 22 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 Ethicon, Inc. devices

FDA 510(k) Submission Details - K780567

510(k) Number K780567 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 1978
Decision Date April 28, 1978
Days to Decision 22 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
103d faster than avg
Panel avg: 125d · This submission: 22d
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 53
Devices cleared under the same product code (DWS) and FDA review panel - the closest regulatory comparables to K780567.
SILICONE SURGICAL VESSEL LOOPS
K791370 · Conphar, Inc. · Aug 1979
GRAFT TUNNELER
K790124 · Narco Scientific · Feb 1979
SURGITEK DISPOSABLE FLO-RESTER
K781336 · Medical Engineering Corp. · Oct 1978
HUANG VEIN HOLDER, #21-8011
K771026 · Codman & Shurtleff, Inc. · Jun 1977
ANASTOMASIS OCCLUDER
K761328 · Medical Engineering Corp. · Feb 1977
67-8006 DARLING-LINTON AORTIC TOURN.
K761161 · Codman & Shurtleff, Inc. · Dec 1976