Cleared Traditional

K070743 - Z6 STIMULATOR

K070743 is an FDA 510(k) clearance for Z6 STIMULATOR, manufactured by St Cardio Technologies, LLC. The device is a Class 2 Cardiovascular device with product code JOQ cleared through the Traditional 510(k) pathway after a 108-day FDA review.

K070743 · St Cardio Technologies, LLC · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Jul 2007
Decision
108d
Days
Class 2
Risk

K070743 is an FDA 510(k) clearance for the Z6 STIMULATOR. Classified as Generator, Pulse, Pacemaker, External Programmable (for Electrophysiological Studies Only) (product code JOQ), Class II - Special Controls.

Submitted by St Cardio Technologies, LLC (Broomfield, US). The FDA issued a Cleared decision on July 2, 2007 after a review of 108 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1750 - 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 St Cardio Technologies, LLC devices

FDA 510(k) Submission Details - K070743

510(k) Number K070743 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 2007
Decision Date July 02, 2007
Days to Decision 108 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
17d faster than avg
Panel avg: 125d · This submission: 108d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JOQ Device Classification - Class 2, Special Controls

Product Code JOQ Generator, Pulse, Pacemaker, External Programmable (for Electrophysiological Studies Only)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1750
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 - JOQ Generator, Pulse, Pacemaker, External Programmable (for Electrophysiological Studies Only)

All 9
Devices cleared under the same product code (JOQ) and FDA review panel - the closest regulatory comparables to K070743.
Bloom2 Programmable Electrophysiology Stimulator
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K991293 · Fischer Medical Technologies, Inc. · May 2000
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K963579 · Radionics, Inc. · Nov 1996
MEDTRONIC MODEL 5328 PROGRAMMABLE STIMULATOR
K861368 · Medtronic Vascular · Aug 1986
EXTERNAL PACEMAKER TELECTRONICS TE200
K852746 · Seamed Corp. · Sep 1985
CORDIS ELECTROPHYSIOLOGY STIMULATOR
K844815 · Cordis Corp. · Jun 1985