Data / Medical devices / United States / Cardiocommand, Inc.

Cardiocommand, Inc.: FDA-registered device maker in Tampa, FL, United States, 4 510(k) clearances and 2 PMA approvals

Name: Cardiocommand, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Cardiocommand, Inc. is registered with the FDA (registration 1927197) in Tampa, FL, United States. It lists 4 device types. The FDA files 4 510(k) clearances and 2 PMA approvals under its listings, the newest dated July 31, 2008. 4 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 1927197
Address: 4920 West Cypress Street Suite 110, Tampa, FL, United States, 33607
Owner or operator: CARDIOCOMMAND, INC. (1927197)
Roles: Complaint file establishment, Contract manufacturer, Manufacturer
First device listed: December 6, 2007
Registered through: 2026
Brand names listed: Octapolar, TAPCATH, TAPSCOPE, TapCath, TapSystem Model 2A, statMAP NIBP Device

Devices it lists

Device	Product code	Class	Role	Source
Catheter, Electrode Recording, Or Probe, Electrode Recording	DRF	2	Manufacturer	accessdata.fda.gov
Stethoscope, Esophageal, With Electrical Conductors	BZT	2	Manufacturer	accessdata.fda.gov
System, Esophageal Pacing	LPA	3	Manufacturer	accessdata.fda.gov
System, Measurement, Blood-Pressure, Non-Invasive	DXN	2	Complaint file establishment, Contract manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
July 31, 2008	K072109	STATMAP, MODEL 7200	DXN	Substantially Equivalent	Ramsey Medical, Inc.	accessdata.fda.gov
April 26, 1991	K904943	TAPSCOPE ESOPHAGEAL CARDIAC RECORDING STETHOSCOPE	BZT	Substantially Equivalent	Arzco Medical Electronics, Inc.	accessdata.fda.gov
March 29, 1991	K905831	ARZCO OCTAPOLAR ESOPHAGEAL CARDIAC RECORD CATH	DRF	Substantially Equivalent	Arzco Medical Electronics, Inc.	accessdata.fda.gov
January 18, 1991	K903136	ARZO TAPCATH ESOPHAGEAL RECORDING CATHETER	DRF	Substantially Equivalent	Arzco Medical Electronics, Inc.	accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

Approved	PMA number	Device	Product code	Supplements	Latest decision	Source
December 30, 1986	P860008	ARZCO TRANSESOPHAGEAL CARDIAC STIMULATOR MODEL 7	LPA	17	June 19, 2017	accessdata.fda.gov
April 30, 1986	P840002	STAT-PACE II	LPA	8	March 24, 2016	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
June 24, 2019	83173	Class III	Terminated	TAPSYSTEM Model 2A, REF 8002A	There is a potential for an assembly error resulting in the battery wire being connected to the ON/OFF power switch incorrectly.	accessdata.fda.gov
May 10, 2019	82803	Class III	Terminated	CardioCommand, Inc. Transesophageal Cardiac Pacing and Recording System, Model 7A, REF 0101 - Product Usage: Indications for Use: - Temporary left atrial pacing to treat bradycardia, hypotension or AV junctional rhythm -	Possible corrosion of the battery contact(s).	accessdata.fda.gov
October 25, 2010	58302	Not yet classified	Terminated	REF #200***TAPSCOPE 550. Each pouch contains one (1) 18 French esophageal stethoscope with bipolar pacing and recording electrodes with a YSI 400 series male connector thermistor. LOT xxxxxxx 400095-0200-C 100902. www.ca	CardioCommand, Inc. is recalling their TAPSCOPE 550 esophageal pacing/recording catheters because there maybe electrical discontinuity, which can result in the inability to reliably pace and/or record ECG.	accessdata.fda.gov
October 27, 2003	27606	Not yet classified	Terminated	The device is labeled as AMS TAPSYSTEM Model 2A Esophageal Pulse generator (used in the Operating Room at Hospitals) and is labeled as ''MANUFACTURED FOR ARZCO MEDICAL SYSTEMS, INC. PO BOX 1048, TAMPA, FL 33601 MODEL S/N	The device may exhibit spurious heart rate increase during esophageal atrial pacing during simultaneous adjacent use of electrosurgical coagulation devices.	accessdata.fda.gov

Compare with other makers

Updated June 19, 2017. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.