Cleared Traditional

K850968 - MEDTRONIC MODEL 4016 BIPOLAR ENDOCARDIA...

K850968 is the FDA 510(k) clearance for MEDTRONIC MODEL 4016 BIPOLAR ENDOCARDIA... by Medtronic Vascular. It is a Class 2 Cardiovascular device (product code DTD) cleared through the Traditional 510(k) pathway after a 174-day FDA review.

K850968 · Medtronic Vascular · Cardiovascular device
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Aug 1985
Decision
174d
Days
Class 2
Risk

K850968 is an FDA 510(k) clearance for the MEDTRONIC MODEL 4016 BIPOLAR ENDOCARDIAL SCREW-IN. Classified as Pacemaker Lead Adaptor (product code DTD), Class II - Special Controls.

Submitted by Medtronic Vascular (Minneapolis, US). The FDA issued a Cleared decision on August 29, 1985 after a review of 174 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3620 - 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 Medtronic Vascular devices

Submission Details

510(k) Number K850968 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 1985
Decision Date August 29, 1985
Days to Decision 174 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
49d slower than avg
Panel avg: 125d · This submission: 174d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DTD Pacemaker Lead Adaptor
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3620
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DTD Pacemaker Lead Adaptor

All 84
Devices cleared under the same product code (DTD) and FDA review panel - the closest regulatory comparables to K850968.
MODEL 366-08 ADAPTAID CONNECTOR ADAPTER
K860832 · Intermedics, Inc. · Mar 1986
IMPLANTABLE ELECTRODE ADAPTOR ASSEMBLY
K854997 · Telectronics, Inc. · Feb 1986
BIOPORE 493-05 ENDOCARDIAL IMPLANTABLE PACING LEAD
K844814 · Intermedics, Inc. · Aug 1985
MEDTRONIC MODEL 5561
K852356 · Medtronic Vascular · Aug 1985
329 CORDIS ENCOR PREVENOUS ARTRIAL & VENTRICULAR
K852253 · Cordis Corp. · Jul 1985
MODEL 483-06 POLYFLEX IMPLANTABLE PACING LEAD
K851457 · Intermedics, Inc. · Jul 1985