Cleared Traditional

K003918 - OSCOR PERMANENT PACING LEAD RZ MODEL SERIES

K003918 is an FDA 510(k) clearance for OSCOR PERMANENT PACING LEAD RZ MODEL SERIES, manufactured by Oscor, Inc.. The device is a Class 3 Cardiovascular device with product code DTB cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K003918 · Oscor, Inc. · Cardiovascular device
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May 2001
Decision
154d
Days
Class 3
Risk

K003918 is an FDA 510(k) clearance for the OSCOR PERMANENT PACING LEAD RZ MODEL SERIES. Classified as Permanent Pacemaker Electrode (product code DTB), Class III - Premarket Approval.

Submitted by Oscor, Inc. (Palm Harbor, US). The FDA issued a Cleared decision on May 22, 2001 after a review of 154 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 Oscor, Inc. devices

FDA 510(k) Submission Details - K003918

510(k) Number K003918 FDA.gov
FDA Decision Cleared Substantially Equivalent - Third Party Review (ST)
Date Received December 19, 2000
Decision Date May 22, 2001
Days to Decision 154 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
29d slower than avg
Panel avg: 125d · This submission: 154d
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 K003918.
MEROX BIPOLAR HIGH IMPEDANCE LEAD MODELS: MEX 53/13-BP
K010281 · Biotronik, Inc. · Apr 2002
PERMANENT PACING LEAD, MODELS PETITE, PETITE R, J, RJ, PETITE B, RB, JB, RJB
K020669 · Oscor, Inc. · Mar 2002
PERMANENT PACING LEAD W/POLARIS COATED TIPS, VARIOUS MODELS
K013339 · Oscor, Inc. · Nov 2001
PACING LEADS, GUIDE WIRES, AND VARIOUS ACCESSORIES
K003072 · Biotronik, Inc. · Jan 2001
ELOX 45-BP, MODEL 330 132, EFH-27, MODEL 331 549, EXTENSION TOOL, MODEL 331 668
K001413 · Biotronik, Inc. · Jun 2000
EX 45-BP, MODEL 330 132
K994240 · Biotronik, Inc. · Apr 2000