Cleared Traditional

K833547 - ROTARY VASCULAR KNIFE

K833547 is an FDA 510(k) clearance for ROTARY VASCULAR KNIFE, manufactured by Formedco, Inc.. The device is a Class 1 Cardiovascular device with product code DWS cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K833547 · Formedco, Inc. · Cardiovascular device
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Jan 1984
Decision
106d
Days
Class 1
Risk

K833547 is an FDA 510(k) clearance for the ROTARY VASCULAR KNIFE. Classified as Instruments, Surgical, Cardiovascular (product code DWS), Class I - General Controls.

Submitted by Formedco, Inc. (Walker, US). The FDA issued a Cleared decision on January 26, 1984 after a review of 106 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 Formedco, Inc. devices

FDA 510(k) Submission Details - K833547

510(k) Number K833547 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 1983
Decision Date January 26, 1984
Days to Decision 106 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
19d faster than avg
Panel avg: 125d · This submission: 106d
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 54
Devices cleared under the same product code (DWS) and FDA review panel - the closest regulatory comparables to K833547.
GORE-TEX TUNNELER
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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
LEATHER VALVULOTOME
K821569 · American V. Mueller · May 1982