Cleared Traditional

MODEL P IN-LINE BIPOLAR ENDOCARDIAL TINED LEAD (K915188) - FDA 510(k) Clearance

Class III device cleared through the 510(k) pathway via substantial equivalence to a legally marketed predicate.

K915188 · Cook Pacemaker Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1992
Decision
298d
Days
Class 3
Risk

K915188 is an FDA 510(k) clearance for the MODEL P IN-LINE BIPOLAR ENDOCARDIAL TINED LEAD. Classified as Permanent Pacemaker Electrode (product code DTB), Class III - Premarket Approval.

Submitted by Cook Pacemaker Corp. (Leechburg, US). The FDA issued a Cleared decision on September 11, 1992 after a review of 298 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3680 - 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: High-complexity regulatory submission. High regulatory complexity profile. 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 Cook Pacemaker Corp. devices

Submission Details

510(k) Number K915188 FDA.gov
FDA Decision Cleared Substantially Equivalent - Product Development Protocol (SESP)
Date Received November 18, 1991
Decision Date September 11, 1992
Days to Decision 298 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
173d slower than avg
Panel avg: 125d · This submission: 298d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DTB Permanent Pacemaker Electrode
Device Class Class 3 - Premarket Approval
CFR Regulation 21 CFR 870.3680
What this classification means

Class III devices typically require Premarket Approval (PMA) with clinical evidence. Clearance through 510(k) for Class III devices is granted only when substantial equivalence to a valid predicate can be established.

Regulatory Peers - DTB Permanent Pacemaker Electrode

All 187
Devices cleared under the same product code (DTB) and FDA review panel - the closest regulatory comparables to K915188.
CARDIFIX ENDOCARDIAL PACING LEAD
K922042 · Intermedics, Inc. · Apr 1993
MODELS 438-05 AND 435-05 IMPLANTABLE PACING LEAD
K922972 · Intermedics, Inc. · Jan 1993
MEDTRONIC MODELS 5069 AND 5071 MYOCARDIAL PACING
K915736 · Medtronic Vascular · Dec 1992
MODELS 6917T, 6917AT & 4951M EPICARDIAL PACE LEADS
K921124 · Medtronic Vascular · May 1992
PERMANENT CARDIAC PACING LEADS AND ADAPTORS
K912464 · Medtronic Vascular · Feb 1992
MEDTRONIC UNIPOLAR, POLY PAC LEAD-BARR COAT COILS
K913288 · Medtronic Vascular · Oct 1991