Cleared Traditional

SILICONE SURGICAL VESSEL LOOPS (K791370) - FDA 510(k) Clearance

Class I Cardiovascular device.

K791370 · Conphar, Inc. · Cardiovascular device
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Aug 1979
Decision
10d
Days
Class 1
Risk

K791370 is an FDA 510(k) clearance for the SILICONE SURGICAL VESSEL LOOPS. Classified as Instruments, Surgical, Cardiovascular (product code DWS), Class I - General Controls.

Submitted by Conphar, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 3, 1979 after a review of 10 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 Conphar, Inc. devices

Submission Details

510(k) Number K791370 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 1979
Decision Date August 03, 1979
Days to Decision 10 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
115d faster than avg
Panel avg: 125d · This submission: 10d
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 13
Devices cleared under the same product code (DWS) and FDA review panel - the closest regulatory comparables to K791370.
CASTROVIEJO VASCULAR SCISSORS
K792576 · Edward Weck, Inc. · Dec 1979
AORTIC OCCLUDER #000390
K792088 · Edward Weck, Inc. · Oct 1979
CARDIOVASCULAR INSTRUMENTS-VARIOUS
K791710 · Edward Weck, Inc. · Sep 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