Cleared Traditional

K032613 - TEMPORARY TRANSVENOUS PACEMAKER PLACEMENT ASSIST DEVICE

K032613 is an FDA 510(k) clearance for TEMPORARY TRANSVENOUS PACEMAKER PLACEME..., manufactured by Peter M. Rothenberg, M.D.. The device is a Class 2 Cardiovascular device with product code LDF cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K032613 · Peter M. Rothenberg, M.D. · Cardiovascular device
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Nov 2003
Decision
87d
Days
Class 2
Risk

K032613 is an FDA 510(k) clearance for the TEMPORARY TRANSVENOUS PACEMAKER PLACEMENT ASSIST DEVICE. Classified as Electrode, Pacemaker, Temporary (product code LDF), Class II - Special Controls.

Submitted by Peter M. Rothenberg, M.D. (San Clemente, US). The FDA issued a Cleared decision on November 20, 2003 after a review of 87 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Peter M. Rothenberg, M.D. devices

FDA 510(k) Submission Details - K032613

510(k) Number K032613 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 2003
Decision Date November 20, 2003
Days to Decision 87 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 125d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LDF Device Classification - Class 2, Special Controls

Product Code LDF Electrode, Pacemaker, Temporary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3680
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 - LDF Electrode, Pacemaker, Temporary

All 92
Devices cleared under the same product code (LDF) and FDA review panel - the closest regulatory comparables to K032613.
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