Cleared Traditional

Z6 STIMULATOR (K070743) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K070743 · St Cardio Technologies, LLC · Cardiovascular device
Download Printable Device Report (PDF)
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

Submission Details

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.

Device Classification

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 17
Devices cleared under the same product code (JOQ) and FDA review panel - the closest regulatory comparables to K070743.
Bloom2 Programmable Electrophysiology Stimulator
K173439 · Fischer Medical · Mar 2018
MEDTRONIC MODEL 5328 PROGRAMMABLE STIMULATOR
K861368 · Medtronic Vascular · Aug 1986
CORDIS ELECTROPHYSIOLOGY STIMULATOR
K844815 · Cordis Corp. · Jun 1985
MEDTRONIC MODEL 5328 PROGRAM-STIMULATOR
K851091 · Medtronic Vascular · Apr 1985
PROGRAMMABLE STIMULATOR 5326
K843718 · Medtronic Vascular · Sep 1984
PROGRAMMABLE STIMULATOR 2352
K833421 · Medtronic Vascular · Jan 1984