Cleared Traditional

TEMPORARY PACING LEAD, SERIES TBB, MODEL HELIOS (TM)

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

About This 510(k) Submission

K072770 is an FDA 510(k) clearance for the TEMPORARY PACING LEAD, SERIES TBB, MODEL HELIOS (TM), a Electrode, Pacemaker, Temporary (Class II — Special Controls, product code LDF), submitted by Oscor, Inc. (Palm Harbor, US). The FDA issued a Cleared decision on January 22, 2008, 116 days after receiving the submission on September 28, 2007. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3680.

Submission Details

510(k) Number K072770 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code LDF — Electrode, Pacemaker, Temporary
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.3680

Similar Devices — LDF Electrode, Pacemaker, Temporary

All 127
Bioptimal Bipolar Pacing Catheter
K242863 · Bioptimal International Pte. , Ltd. · Jun 2025
Bard? Temporary Pacing Electrode Catheter Needle / Cannula (Introducer)
K251186 · C.R. Bard, Inc. · May 2025
Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 4Fr. (006221P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 5Fr. (006225P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 125 cm, 6Fr. (006241P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 125 cm, 7Fr. (006242P); NBIH? Temporary Pacing Electrode Catheter,
K241334 · C.R. Bard, Inc. · Jan 2025
Rotatable Connector (5944RL)
K241199 · Shenzhen Launch Electrical Co., Ltd. · Jan 2025
Streamline Unipolar Pediatric Temporary Pacing Lead (6491) Streamline Unipolar Temporary Atrial Pacing Lead (6492) Streamline Unipolar Temporary Myocardial Pacing Wire (6494) Streamline Bipolar Temporary Myocardial Pacing Lead (6495) Streamline Unipolar Temporary Myocardial Pacing Lead (6500)
K242705 · Medtronic, Inc. · Jan 2025
TME Temporary Myocardial Electrode
K232261 · Osypka AG · Apr 2024