Cleared Traditional

K072770 - TEMPORARY PACING LEAD

K072770 is an FDA 510(k) clearance for TEMPORARY PACING LEAD, manufactured by Oscor, Inc.. The device is a Class 2 Cardiovascular device with product code LDF cleared through the Traditional 510(k) pathway after a 116-day FDA review.

K072770 · Oscor, Inc. · Cardiovascular device
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Jan 2008
Decision
116d
Days
Class 2
Risk

K072770 is an FDA 510(k) clearance for the TEMPORARY PACING LEAD, SERIES TBB, MODEL HELIOS (TM). Classified as Electrode, Pacemaker, Temporary (product code LDF), Class II - Special Controls.

Submitted by Oscor, Inc. (Palm Harbor, US). The FDA issued a Cleared decision on January 22, 2008 after a review of 116 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. 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 - K072770

510(k) Number K072770 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2007
Decision Date January 22, 2008
Days to Decision 116 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
9d faster than avg
Panel avg: 125d · This submission: 116d
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 82
Devices cleared under the same product code (LDF) and FDA review panel - the closest regulatory comparables to K072770.
Pacel Bipolar Pacing Catheters
K152784 · St Jude Medical · Oct 2015
Chandler Transluminal Bipolar Pacing Probe, Flextip Transluminal Bipolar Pacing Probe
K152633 · Edwards Lifesciences, LLC · Oct 2015
UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD, UNIPOLAR TEMPORARY ATRIAL PACING LEAD, UNIPOLAR TEMPORARY MYOCARDIAL PACING
K140972 · Medtronic, Inc. · Jun 2014
MODEL 6416 TEMPORARY PACING LEAD SYSTEM
K042190 · Medtronic Vascular · Sep 2004
DETECT SURGICAL PACING AND MAPPING TOOL
K040812 · Medtronic Vascular · Sep 2004
STEELEX ELECTRODE SET
K030556 · Aesculap, Inc. · Apr 2003