Cleared Traditional

K821569 - LEATHER VALVULOTOME

K821569 is an FDA 510(k) clearance for LEATHER VALVULOTOME, manufactured by American V. Mueller. The device is a Class 1 Cardiovascular device with product code DWS cleared through the Traditional 510(k) pathway .

K821569 · American V. Mueller · Cardiovascular device
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May 1982
Decision
-
Days
Class 1
Risk

K821569 is an FDA 510(k) clearance for the LEATHER VALVULOTOME. Classified as Instruments, Surgical, Cardiovascular (product code DWS), Class I - General Controls.

Submitted by American V. Mueller (Mchenry, US). The FDA issued a Cleared decision on May 27, 1982.

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 American V. Mueller devices

FDA 510(k) Submission Details - K821569

510(k) Number K821569 FDA.gov
FDA Decision Cleared Substantially Equivalent - Product Development Protocol (SESP)
Date Received May 27, 1982
Decision Date May 27, 1982
Days to Decision -
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
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 K821569.
CATEGORY 1 CIRCULATORY SYSTEM DEVICE
K840305 · Imm Enterprises , Ltd. · Apr 1984
LEATHER VALVE CUTTER
K831455 · American V. Mueller · Jul 1983
SCANLAN SINGLE-USE AORTA PUNCH
K823764 · Scanlan Intl., Inc. · Mar 1983
DEKNATEL DISPOSABLE GOOSEN VASCULAR PNCH
K820258 · Howmedica Corp. · Mar 1982
DEKNATEL GOOSEN VASCULAR PUNCH BLADES
K802079 · Howmedica Corp. · Sep 1980
AIR ASPIRATOR NEEDLE
K801393 · Texas Medical Products, Inc. · Jun 1980