Cleared Traditional

K870034 - MODEL PY...U UNIPOLAR & BIPOLAR PACING ...

K870034 is the FDA 510(k) clearance for MODEL PY...U UNIPOLAR & BIPOLAR PACING ... by Oscor Medical Corp.. It is a Class 3 Cardiovascular device (product code DTB) cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K870034 · Oscor Medical Corp. · Cardiovascular device
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Mar 1987
Decision
57d
Days
Class 3
Risk

K870034 is an FDA 510(k) clearance for the MODEL PY...U UNIPOLAR & BIPOLAR PACING LEAD. Classified as Permanent Pacemaker Electrode (product code DTB), Class III - Premarket Approval.

Submitted by Oscor Medical Corp. (Palm Harbor, US). The FDA issued a Cleared decision on March 3, 1987 after a review of 57 days - a notably fast clearance 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 Oscor Medical Corp. devices

Submission Details

510(k) Number K870034 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 05, 1987
Decision Date March 03, 1987
Days to Decision 57 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
68d faster than avg
Panel avg: 125d · This submission: 57d
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 386
Devices cleared under the same product code (DTB) and FDA review panel - the closest regulatory comparables to K870034.
MODEL 435-03 SIDE HOOK IMPLANTABLE PACING LEAD
K870948 · Intermedics, Inc. · Apr 1987
RESUBMISSION OF MODEL 030-437 IMPLANT. ELECTRODE
K870610 · Telectronics, Inc. · Mar 1987
ADDITIONAL CARDIAC PACING LEADS #1020 THROUGH 1035
K870824 · Pacesetter Systems · Mar 1987
MODEL 366-13 ADAPTAID STEP DOWN ADAPTER
K864326 · Intermedics, Inc. · Jan 1987
MODEL 436-01 BIOPORE IMPLANTABLE PACING LEAD
K862051 · Intermedics, Inc. · Jan 1987
MEDTRONIC MODEL 5013
K863536 · Medtronic Vascular · Jan 1987