Cleared Traditional

K831455 - LEATHER VALVE CUTTER

K831455 is an FDA 510(k) clearance for LEATHER VALVE CUTTER, manufactured by American V. Mueller. The device is a Class 1 Cardiovascular device with product code DWS cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K831455 · American V. Mueller · Cardiovascular device
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Jul 1983
Decision
62d
Days
Class 1
Risk

K831455 is an FDA 510(k) clearance for the LEATHER VALVE CUTTER. Classified as Instruments, Surgical, Cardiovascular (product code DWS), Class I - General Controls.

Submitted by American V. Mueller (Walker, US). The FDA issued a Cleared decision on July 7, 1983 after a review of 62 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 American V. Mueller devices

FDA 510(k) Submission Details - K831455

510(k) Number K831455 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 1983
Decision Date July 07, 1983
Days to Decision 62 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
63d faster than avg
Panel avg: 125d · This submission: 62d
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 K831455.
GORE-TEX TUNNELER
K844584 · W.L. Gore & Associates, Inc. · Jan 1985
PMA ANGIOGRAPHY TRAY
K841468 · Professional Medical Services · Jun 1984
CATEGORY 1 CIRCULATORY SYSTEM DEVICE
K840305 · Imm Enterprises , Ltd. · Apr 1984
SCANLAN SINGLE-USE AORTA PUNCH
K823764 · Scanlan Intl., Inc. · Mar 1983
LEATHER VALVULOTOME
K821569 · American V. Mueller · May 1982
DEKNATEL DISPOSABLE GOOSEN VASCULAR PNCH
K820258 · Howmedica Corp. · Mar 1982