Cleared Traditional

K823764 - SCANLAN SINGLE-USE AORTA PUNCH

K823764 is an FDA 510(k) clearance for SCANLAN SINGLE-USE AORTA PUNCH, manufactured by Scanlan Intl., Inc.. The device is a Class 1 Cardiovascular device with 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.

FDA 510(k) Submission Details - K823764

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 125d · This submission: 100d
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 70
Devices cleared under the same product code (DWS) and FDA review panel - the closest regulatory comparables to K823764.
CATEGORY 1 CIRCULATORY SYSTEM DEVICE
K840305 · Imm Enterprises , Ltd. · Apr 1984
ROTARY VASCULAR KNIFE
K833547 · Formedco, Inc. · Jan 1984
LEATHER VALVE CUTTER
K831455 · American V. Mueller · Jul 1983
KELLY-WICK TANNELER
K830471 · Intl. Medical Prosthetics Research · Mar 1983
CARDIAC ELEVATOR
K823094 · Cardio Surgical Research, Inc. · Dec 1982
ROTARY VASCULAR KNIFE
K822829 · Medco Products, Co., Inc. · Nov 1982
K823764 · SCANLAN SINGLE-USE AORTA PUNCH
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