Cleared Traditional

K761161 - 67-8006 DARLING-LINTON AORTIC TOURN.

K761161 is an FDA 510(k) clearance for 67-8006 DARLING-LINTON AORTIC TOURN., manufactured by Codman & Shurtleff, Inc.. The device is a Class 1 Cardiovascular device with product code DWS cleared through the Traditional 510(k) pathway after a 7-day FDA review.

K761161 · Codman & Shurtleff, Inc. · Cardiovascular device
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Dec 1976
Decision
7d
Days
Class 1
Risk

K761161 is an FDA 510(k) clearance for the 67-8006 DARLING-LINTON AORTIC TOURN.. Classified as Instruments, Surgical, Cardiovascular (product code DWS), Class I - General Controls.

Submitted by Codman & Shurtleff, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 6, 1976 after a review of 7 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 Codman & Shurtleff, Inc. devices

FDA 510(k) Submission Details - K761161

510(k) Number K761161 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 29, 1976
Decision Date December 06, 1976
Days to Decision 7 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
118d faster than avg
Panel avg: 125d · This submission: 7d
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 K761161.
AORTIC PUMP
K780567 · Ethicon, Inc. · Apr 1978
HUANG VEIN HOLDER, #21-8011
K771026 · Codman & Shurtleff, Inc. · Jun 1977
ANASTOMASIS OCCLUDER
K761328 · Medical Engineering Corp. · Feb 1977
COOLEY ANGLED SCISSOR - 1MM PROBE POINT
K760791 · V. Mueller O.V. Baxter Healthcare Corp. · Nov 1976
SCISSOR - 1.5MM PROBE POINT, ANGLED
K760792 · V. Mueller O.V. Baxter Healthcare Corp. · Nov 1976
CAROTID ARTERY ARTERIOTOMY CLOSURE CLAMP
K760645 · Pilling Co. · Sep 1976