Cleared Traditional

K862051 - MODEL 436-01 BIOPORE IMPLANTABLE PACING...

K862051 is an FDA 510(k) clearance for MODEL 436-01 BIOPORE IMPLANTABLE PACING..., manufactured by Intermedics, Inc.. The device is a Class 3 Cardiovascular device with product code DTB cleared through the Traditional 510(k) pathway after a 222-day FDA review.

K862051 · Intermedics, Inc. · Cardiovascular device
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Jan 1987
Decision
222d
Days
Class 3
Risk

K862051 is an FDA 510(k) clearance for the MODEL 436-01 BIOPORE IMPLANTABLE PACING LEAD. Classified as Permanent Pacemaker Electrode (product code DTB), Class III - Premarket Approval.

Submitted by Intermedics, Inc. (Freeport, US). The FDA issued a Cleared decision on January 6, 1987 after a review of 222 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 Intermedics, Inc. devices

FDA 510(k) Submission Details - K862051

510(k) Number K862051 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 29, 1986
Decision Date January 06, 1987
Days to Decision 222 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
97d slower than avg
Panel avg: 125d · This submission: 222d
Pathway characteristics
Predicate-based equivalence.

DTB Device Classification - Class 3, Premarket Approval

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 396
Devices cleared under the same product code (DTB) and FDA review panel - the closest regulatory comparables to K862051.
ADDITIONAL CARDIAC PACING LEADS #1020 THROUGH 1035
K870824 · Pacesetter Systems · Mar 1987
MODEL PY...U UNIPOLAR & BIPOLAR PACING LEAD
K870034 · Oscor Medical Corp. · Mar 1987
MODEL 366-13 ADAPTAID STEP DOWN ADAPTER
K864326 · Intermedics, Inc. · Jan 1987
MEDTRONIC MODEL 5013
K863536 · Medtronic Vascular · Jan 1987
CCS POLYSAFE(TM) ENDOCARDIAL PACING LEAD
K864601 · Cardiac Control Systems, Inc. · Jan 1987
ANCOR PERVENOUS ACTIVE FIXATION UNIPOLAR LEAD
K864640 · Cordis Corp. · Jan 1987