Cleared Traditional

K760351 - CATHETER

K760351 is the FDA 510(k) clearance for CATHETER by Sherwood Medical Industries. It is a Class 1 Cardiovascular device (product code DWS) cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K760351 · Sherwood Medical Industries · Cardiovascular device
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Aug 1976
Decision
21d
Days
Class 1
Risk

K760351 is an FDA 510(k) clearance for the CATHETER, ARGYLE THORACIC. Classified as Instruments, Surgical, Cardiovascular (product code DWS), Class I - General Controls.

Submitted by Sherwood Medical Industries (Mchenry, US). The FDA issued a Cleared decision on August 23, 1976 after a review of 21 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 Sherwood Medical Industries devices

Submission Details

510(k) Number K760351 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 1976
Decision Date August 23, 1976
Days to Decision 21 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
104d faster than avg
Panel avg: 125d · This submission: 21d
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 32
Devices cleared under the same product code (DWS) and FDA review panel - the closest regulatory comparables to K760351.
CAROTID ARTERY CLAMP W/PILLING LMM
K760646 · Pilling Co. · Sep 1976
TIBIAL ARTERY CLAMP W/ATRAUGRIP JAWS
K760648 · Pilling Co. · Sep 1976
SMALL VESSEL CANNULA
K760624 · Cobe Laboratories, Inc. · Sep 1976
TAPE, VASCULAR, 1/4 DACRON
K760087 · Meadox Medicals, Div. Boston Scientific Corp. · Jul 1976
CATHETER, THORACIC DRAIN
K760136 · Sherwood Medical Industries · Jul 1976