Cleared Traditional

K822829 - ROTARY VASCULAR KNIFE

K822829 is an FDA 510(k) clearance for ROTARY VASCULAR KNIFE, manufactured by Medco Products, Co., Inc.. The device is a Class 1 Cardiovascular device with product code DWS cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K822829 · Medco Products, Co., Inc. · Cardiovascular device
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Nov 1982
Decision
57d
Days
Class 1
Risk

K822829 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 Medco Products, Co., Inc. (Walker, US). The FDA issued a Cleared decision on November 17, 1982 after a review of 57 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 Medco Products, Co., Inc. devices

FDA 510(k) Submission Details - K822829

510(k) Number K822829 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 1982
Decision Date November 17, 1982
Days to Decision 57 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
68d faster than avg
Panel avg: 125d · This submission: 57d
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 K822829.
CATEGORY 1 CIRCULATORY SYSTEM DEVICE
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LEATHER VALVE CUTTER
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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
DEKNATEL GOOSEN VASCULAR PUNCH BLADES
K802079 · Howmedica Corp. · Sep 1980