CARDIOCOMMAND, INC.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
1927197	1927197	CARDIOCOMMAND, INC.	1	N	2026-01-01	4920 WEST CYPRESS STREET SUITE 110 TAMPA FL US 33607

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDID	Product	Phone	Email
00856233005066	Tapsystem - A pulse generator system for the treatment of cardiac dysrhythmias, (unpackaged unit).	(800) 231-6370	cconley@CardioCommand.com
00856233005110	Model 7A - Interface cable between 7A Stimulator and Model 3 preamplifier.	(800) 231-6370	cconley@CardioCommand.com
00856233005134	Model 7A - Patient lead wire for use with the Model 7A stimulator; white, right arm.	(800) 231-6370	cconley@CardioCommand.com
10856233005063	Tapsystem - A pulse generator system for the treatment of cardiac dysrhythmias, (single unit package).	(800) 231-6370	cconley@CardiCommand.com
10856233005155	Tapsystem - A pulse generator system for the treatment of cardiac dysrhythmias; re-manufactured, (single unit package).	(800) 231-6370	cconley@CardioCommand.com
10856233005162	Model 7A - Transesophageal cardiac stimulator intended for the temporary pacing of the atrium and designed for use with the Model 3 Preamplifier for the recording of esophageal cardiac signals (single unit package).	(800) 231-6370	cconley@CardioCommand.com
10856233005179	Model 7A - Transesophageal cardiac stimulator intended for the temporary pacing of the atrium and designed for use with the Model 3 Preamplifier for the recording of esophageal cardiac signals; re-manufactured, (single unit package).	(800) 231-6370	cconley@CardioCommand.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
33635	1867300394	P860008	ARZCO TRANSESOPHAGEAL CARDIAC STIMULATOR MODEL 7	LPA	1986-12-30
33635	1493097844	P840002	STAT-PACE II	LPA	1986-04-30
33635	1950564919	K905831	ARZCO OCTAPOLAR ESOPHAGEAL CARDIAC RECORD CATH	DRF	1991-03-29
33635	1679865599	K904943	TAPSCOPE ESOPHAGEAL CARDIAC RECORDING STETHOSCOPE	BZT	1991-04-26
33635	1072392476	K903136	ARZO TAPCATH ESOPHAGEAL RECORDING CATHETER	DRF	1991-01-18
33635	1428011889	K072109	STATMAP, MODEL 7200	DXN	2008-07-31

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
DRF	2	1991-03-29
LPA	2	1986-12-30
DXN	1	2008-07-31
BZT	1	1991-04-26

PMA#

TAP SYSTEM 2A

2016-03-24

CARDIOCOMMAND, INC.

TAPCATH AND TAPSCOPE DISPOSABLE TRANSESOPHAGEAL PROBES

2005-02-03

CARDIOCOMMAND, INC.

STAT PACE II

2004-10-01

CARDIOCOMMAND, INC.

EXTERNAL PULSE GENERATOR MODEL 2A, TAPSCOPE 500 SERIES ESOPHAGEAL STETHOSCOPE AND PACING CATHETER, TAPSCOPE 210 ESOPHAGR

2004-08-27

CARDIOCOMMAND, INC.

STAT-PACE II ESOPHAGEAL PACING SYSTEM

1998-05-07

CARDIOCOMMAND, INC.

TAPSYSTEM 2A

1997-10-03

CARDIOCOMMAND, INC.

STAT-PACE II ESOPHAGEAL PACING SYSTEM

1997-09-03

CARDIOCOMMAND, INC.

STAT-PACE II

1994-01-11

CARDIOCOMMAND, INC.

STAT-PACE II

1986-04-30

CARDIOCOMMAND, INC.

GUDID#

Model 7A - Patient lead wire for use with the Model 7A stimulator; black, left arm.

CARDIOCOMMAND, INC.

2015-04-03

Model 7A - Patient lead wire for use with the Model 7A stimulator; white, right arm.

CARDIOCOMMAND, INC.

2015-04-03

Tapsystem - A pulse generator system for the treatment of cardiac dysrhythmias, (single unit package).

CARDIOCOMMAND, INC.

2015-07-22

Tapsystem - A pulse generator system for the treatment of cardiac dysrhythmias; re-manufactured, (single unit package).

CARDIOCOMMAND, INC.

2015-07-22

Model 7A - Transesophageal cardiac stimulator intended for the temporary pacing of the atrium and designed for use with the Model 3 Preamplifier for the recording of esophageal cardiac signals (single unit package).

CARDIOCOMMAND, INC.

2015-04-03

Model 7A - Transesophageal cardiac stimulator intended for the temporary pacing of the atrium and designed for use with the Model 3 Preamplifier for the recording of esophageal cardiac signals; re-manufactured, (single unit package).

CARDIOCOMMAND, INC.

2015-04-03

Tapsystem - A pulse generator system for the treatment of cardiac dysrhythmias, (unpackaged unit).

CARDIOCOMMAND, INC.

2015-07-22

Model 7A - Interface cable between 7A Stimulator and Model 3 preamplifier.

CARDIOCOMMAND, INC.

2015-04-03

Tapsystem - A pulse generator system for the treatment of cardiac dysrhythmias; re-manufactured, (unpackaged).

CARDIOCOMMAND, INC.

2015-07-22

Model 7A - Transesophageal cardiac stimulator intended for the temporary pacing of the atrium and designed for use with the Model 3 Preamplifier for the recording of esophageal cardiac signals; (unpackaged unit).

CARDIOCOMMAND, INC.

2015-04-03

Model 7A - Transesophageal cardiac stimulator intended for the temporary pacing of the atrium and designed for use with the Model 3 Preamplifier for the recording of esophageal cardiac signals; re-manufactured, (unpackaged unit).

CARDIOCOMMAND, INC.

2015-04-03

Model 3 - Amplification and signal processing module designed to interface with CardioCommand esophageal catheters to enable recording of esophageal cardiac signals, (single unit package).

CARDIOCOMMAND, INC.

2015-04-03

Model 3 - Amplification and signal processing module designed to interface with CardioCommand esophageal catheters to enable recording of esophageal cardiac signals; re-manufactured, (single unit package).

CARDIOCOMMAND, INC.

2015-04-03

Tapscope - 18 French, Esophageal stethoscope with bipolar pacing and recording electrodes and a male temperature connector, (single unit package).

CARDIOCOMMAND, INC.

2015-04-03

Tapscope - 18 French, Esophageal stethoscope with bipolar pacing and recording electrodes and a female temperature connector, (single unit package).

CARDIOCOMMAND, INC.

2015-04-08

Tapscope - 10 French esophageal bipolar pacing and recording catheter, (single unit package).

CARDIOCOMMAND, INC.

2015-04-03

Tapscope - 10 French esophageal bipolar pacing and recording catheter with a stainless steel stylet, (single unit package).

CARDIOCOMMAND, INC.

2015-04-03

Tapcath - 5 French esophageal bipolar pacing and recording catheter, (single unit package).

CARDIOCOMMAND, INC.

2015-04-03

Tapcath - 6 French esophageal octapolar recording catheter, (single unit package).

CARDIOCOMMAND, INC.

2015-07-22

Tapsystem - A cable used to connect a patient to a Model 2A pulse generator system for the treatment of cardiac dysrhythmias.

CARDIOCOMMAND, INC.

2015-07-22

EP Connect - A 10 ft. cable that connects Tapcath catheter products to ECG recorders using a modular to pin connector. .

CARDIOCOMMAND, INC.

2015-04-03

EP-Connect - A 10 ft. cable that connects Model 1600 Octapolar catheter products to ECG recorders using modular to pin connector.

CARDIOCOMMAND, INC.

2015-04-03

Model 7A - Instrument cable for 7A Stimulator or Model 3 preamp.

CARDIOCOMMAND, INC.

2015-04-03

EC-View - An ECG adapter for the Tapscope, which provides an esophageal ECG.

CARDIOCOMMAND, INC.

2015-04-03

Model 3 - Amplification and signal processing module designed to interface with CardioCommand esophageal catheters to enable recording of esophageal cardiac signals, (unpackaged unit).

CARDIOCOMMAND, INC.

2015-04-03

Model 3 - Amplification and signal processing module designed to interface with CardioCommand esophageal catheters to enable recording of esophageal cardiac signals; re-manufactured, (unpackaged unit).

CARDIOCOMMAND, INC.

2015-04-03