Cleared Traditional

K790124 - GRAFT TUNNELER

K790124 is the FDA 510(k) clearance for GRAFT TUNNELER by Narco Scientific. It is a Class 1 Cardiovascular device (product code DWS) cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K790124 · Narco Scientific · Cardiovascular device
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Feb 1979
Decision
16d
Days
Class 1
Risk

K790124 is an FDA 510(k) clearance for the GRAFT TUNNELER. Classified as Instruments, Surgical, Cardiovascular (product code DWS), Class I - General Controls.

Submitted by Narco Scientific (Walker, US). The FDA issued a Cleared decision on February 8, 1979 after a review of 16 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 Narco Scientific devices

Submission Details

510(k) Number K790124 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 1979
Decision Date February 08, 1979
Days to Decision 16 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
109d faster than avg
Panel avg: 125d · This submission: 16d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 18
Devices cleared under the same product code (DWS) and FDA review panel - the closest regulatory comparables to K790124.
AORTIC OCCLUDER #000390
K792088 · Edward Weck, Inc. · Oct 1979
CARDIOVASCULAR INSTRUMENTS-VARIOUS
K791710 · Edward Weck, Inc. · Sep 1979
SILICONE SURGICAL VESSEL LOOPS
K791370 · Conphar, Inc. · Aug 1979
AORTIC PUMP
K780567 · Ethicon, Inc. · Apr 1978
HUANG VEIN HOLDER, #21-8011
K771026 · Codman & Shurtleff, Inc. · Jun 1977
67-8006 DARLING-LINTON AORTIC TOURN.
K761161 · Codman & Shurtleff, Inc. · Dec 1976