Cleared Traditional

K894738 - MODEL 6888 LEAD TUNNELER

K894738 is the FDA 510(k) clearance for MODEL 6888 LEAD TUNNELER by Cardiac Pacemakers, Inc.. It is a Class 1 Cardiovascular device (product code DWS) cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K894738 · Cardiac Pacemakers, Inc. · Cardiovascular device
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Sep 1989
Decision
48d
Days
Class 1
Risk

K894738 is an FDA 510(k) clearance for the MODEL 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 September 13, 1989 after a review of 48 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 Cardiac Pacemakers, Inc. devices

Submission Details

510(k) Number K894738 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 1989
Decision Date September 13, 1989
Days to Decision 48 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
77d faster than avg
Panel avg: 125d · This submission: 48d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 25
Devices cleared under the same product code (DWS) and FDA review panel - the closest regulatory comparables to K894738.
G.E. STERILE CT BIOPSY TRAY
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REPLACEMENT PARTS FOR CPI 6888 LEAD TUNNELER
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PHRENIC NERVE PAD & NERVE PAD W/1/4 PERCARDIAL
K890707 · Dlp, Inc. · Apr 1989
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K881717 · Buckman Co., Inc. · Jul 1988
VICKERS ERGOMATIC MICROSURG INSTRU CARDIAC SET
K861745 · Keeler Instruments, Inc. · May 1986