Cleared Traditional

K934727 - REPLACEMENT PARTS FOR CPI 6888 LEAD TUNNELER

K934727 is an FDA 510(k) clearance for REPLACEMENT PARTS FOR CPI 6888 LEAD TUN..., manufactured by Cardiac Pacemakers, Inc.. The device is a Class 1 Cardiovascular device with product code DWS cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K934727 · Cardiac Pacemakers, Inc. · Cardiovascular device
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Jan 1994
Decision
101d
Days
Class 1
Risk

K934727 is an FDA 510(k) clearance for the REPLACEMENT PARTS FOR CPI 6888 LEAD TUNNELER. Classified as Instruments, Surgical, Cardiovascular (product code DWS), Class I - General Controls.

Submitted by Cardiac Pacemakers, Inc. (St. Paul, US). The FDA issued a Cleared decision on January 10, 1994 after a review of 101 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 Cardiac Pacemakers, Inc. devices

FDA 510(k) Submission Details - K934727

510(k) Number K934727 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 1993
Decision Date January 10, 1994
Days to Decision 101 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 125d · This submission: 101d
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 K934727.
G.E. STERILE ANGIOGRAPHIC TRAY
K960139 · GE Medical Systems · Apr 1996
G.E. STERILE CT BIOPSY TRAY
K960144 · GE Medical Systems · Apr 1996
G.E. STERILE DIGITAL ANGIOGRAPHIC TRAY
K960143 · GE Medical Systems · Apr 1996
HYCULT DIAMOND CORONARY BYPASS KNIFE
K900379 · St. Jude Medical, Inc. · Mar 1990
INSULATION PAD
K896307 · Bio-Vascular, Inc. · Jan 1990
MODEL 6888 LEAD TUNNELER
K894738 · Cardiac Pacemakers, Inc. · Sep 1989