Cleared Traditional

TENDRIL, UNIPOLAR ENDOCARDIAL SCREW-IN LEAD (K951087) - FDA 510(k) Clearance

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

K951087 · Pacesetter, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1995
Decision
112d
Days
Class 3
Risk

K951087 is an FDA 510(k) clearance for the TENDRIL, UNIPOLAR ENDOCARDIAL SCREW-IN LEAD. Classified as Permanent Pacemaker Electrode (product code DTB), Class III - Premarket Approval.

Submitted by Pacesetter, Inc. (Sylmar, US). The FDA issued a Cleared decision on June 29, 1995 after a review of 112 days - within the typical 510(k) review window.

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 Pacesetter, Inc. devices

Submission Details

510(k) Number K951087 FDA.gov
FDA Decision Cleared Substantially Equivalent - Third Party Review (ST)
Date Received March 09, 1995
Decision Date June 29, 1995
Days to Decision 112 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
13d faster than avg
Panel avg: 125d · This submission: 112d
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 255
Devices cleared under the same product code (DTB) and FDA review panel - the closest regulatory comparables to K951087.
INTERMEDICS MODEL 430-07 BIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEAD
K954719 · Intermedics, Inc. · Feb 1996
MODELS 5866-45 AND 5866-46 SIZING SLEEVE
K954085 · Medtronic Vascular · Nov 1995
TRANSVENOUS, PERMANENT TINED TARGET TIP PACING LEADS
K951858 · Medtronic Vascular · Oct 1995
MEDTRONIC MODEL 4558M
K940703 · Medtronic Vascular · Nov 1994
MEDTRONIS(R) PACING LEADS AND LEAD ADAPTORS, MODIF
K933055 · Medtronic Vascular · May 1994
MEDTRONIC MODEL 5028 TARGET TIP, BIPOLAR, IMPLANTABLE, TINED, VENTRICULAR, TRANSVENOUS LEAD
K933731 · Medtronic Vascular · Mar 1994