Cleared Traditional

K905300 - PERMANENT PACING LEAD

K905300 is the FDA 510(k) clearance for PERMANENT PACING LEAD by Oscor Medical Corp.. It is a Class 3 Cardiovascular device (product code DTB) cleared through the Traditional 510(k) pathway after a 161-day FDA review.

K905300 · Oscor Medical Corp. · Cardiovascular device
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May 1991
Decision
161d
Days
Class 3
Risk

K905300 is an FDA 510(k) clearance for the PERMANENT 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 May 7, 1991 after a review of 161 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 Medical Corp. devices

Submission Details

510(k) Number K905300 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 27, 1990
Decision Date May 07, 1991
Days to Decision 161 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
36d slower than avg
Panel avg: 125d · This submission: 161d
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 K905300.
ENDOCARDIAL LEADS-MOD. TO THE POLYVINYLPYRROLIDONE
K910924 · Pacesetter Systems · Aug 1991
BIPOLAR SUTURELESS MYOCARDIAL PACING LEADS
K910528 · Possis Medical, Inc. · Aug 1991
OSCOR MEDICAL CORP. PERMANENT PACING PAD
K905182 · Oscor Medical Corp. · May 1991
INTERMEDICS MODEL 431-11 IMPLANT ENDOCARD PAC LEAD
K903948 · Intermedics, Inc. · Apr 1991
INTERMEDICS 430-07 BIPOL IMPLANT ENDOCARD PAC LEAD
K902672 · Intermedics, Inc. · Mar 1991
MODELS 5069/5071 MYOCARDIAL PACING LEADS
K902002 · Medtronic Vascular · Sep 1990