Cleared Traditional

K823764 - SCANLAN SINGLE-USE AORTA PUNCH

K823764 is the FDA 510(k) clearance for SCANLAN SINGLE-USE AORTA PUNCH by Scanlan Intl., Inc.. It is a Class 1 Cardiovascular device (product code DWS) cleared through the Traditional 510(k) pathway after a 100-day FDA review.

K823764 · Scanlan Intl., Inc. · Cardiovascular device
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Mar 1983
Decision
100d
Days
Class 1
Risk

K823764 is an FDA 510(k) clearance for the SCANLAN SINGLE-USE AORTA PUNCH. Classified as Instruments, Surgical, Cardiovascular (product code DWS), Class I - General Controls.

Submitted by Scanlan Intl., Inc. (Mchenry, US). The FDA issued a Cleared decision on March 24, 1983 after a review of 100 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Scanlan Intl., Inc. devices

Submission Details

510(k) Number K823764 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 1982
Decision Date March 24, 1983
Days to Decision 100 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 125d · This submission: 100d
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 34
Devices cleared under the same product code (DWS) and FDA review panel - the closest regulatory comparables to K823764.
TELEFLEX MEDICAL INTRODUCER NEEDLE
K851140 · Teleflexmedical, Inc. · Jun 1985
GORE-TEX TUNNELER
K844584 · W.L. Gore & Associates, Inc. · Jan 1985
CATEGORY 1 CIRCULATORY SYSTEM DEVICE
K840305 · Imm Enterprises , Ltd. · Apr 1984
DEKNATEL DISPOSABLE GOOSEN VASCULAR PNCH
K820258 · Howmedica Corp. · Mar 1982
DEKNATEL GOOSEN VASCULAR PUNCH BLADES
K802079 · Howmedica Corp. · Sep 1980
CASTROVIEJO VASCULAR SCISSORS
K792576 · Edward Weck, Inc. · Dec 1979