FDA.reportPublic FDA data

Tapscope

Primary DI
00856233005035
Brand
Tapscope
Company
CARDIOCOMMAND, INC.
Model
210-S, single pack
Catalog number
102
Device description
10 French esophageal bipolar pacing and recording catheter with a stainless steel stylet, (single unit package).
Published
2015-04-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DRFCatheter, Electrode Recording, Or Probe, Electrode Recording

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DRFCatheter, Electrode Recording, Or Probe, Electrode RecordingCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P860008017
P860008019
P860008020

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P860008017ARZCO TRANSESOPHAGEAL CARDIAC STIMULATOR MODEL 7Cardio Command1986-12-30LPA
P860008019ARZCO TRANSESOPHAGEAL CARDIAC STIMULATOR MODEL 7Cardio Command1986-12-30LPA
P860008020ARZCO TRANSESOPHAGEAL CARDIAC STIMULATOR MODEL 7Cardio Command1986-12-30LPA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10856233005032PackageGS110In Commercial Distribution
00856233005035PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085623300503210856233005032
00856233005035008562330050358562330050350856233005035

GMDN Terms#

Term, Definition table
TermDefinition
Transoesophageal pacing leadA flexible wire with an electrode, insulated with non-conductive material except at its ends, that serves as an electrical conductor to regulate cardiac pacing, with one end connected to an external temporary pacemaker and the other end (electrode) applied through the oesophagus to the heart. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge10French

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(800) 231-6370cconley@CardioCommand.com

Regulatory Flags#

DUNS number
800214827
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00856233005127Model 7ALeft arm patient lead wire80212015-04-03
00856233005134Model 7ARight arm patient lead wire80232015-04-03
10856233005063Tapsystem2A, single pack8002A2015-07-22
10856233005155Tapsystem2A re-man'd, single pack8002A-99992015-07-22
10856233005162Model 7ASingle pack01012015-04-03
10856233005179Model 7ARe-manufactured, single pack0101-99992015-04-03
00856233005066Tapsystem2A, unpackaged8002A2015-07-22
00856233005110Model 7A7A/Mod 3 Interface cable04062015-04-03
00856233005158Tapsystem2A re-man'd, unpackaged8002A-99992015-07-22
00856233005165Model 7AUnpackaged01012015-04-03
00856233005172Model 7ARe-manufactured, unpackaged0101-99992015-04-03
10856233005186Model 3Single pack01042015-04-03
10856233005193Model 3Re-manufactured, single pack0104-99992015-04-03
00856233005004Tapscope550, single pack2002015-04-03
00856233005011Tapscope550F, single pack2502015-04-08
00856233005028Tapscope210, single pack1002015-04-03
00856233005042Tapcath205, single pack1802015-04-03
00856233005059Tapcath1600, single pack16002015-07-22
00856233005073Tapsystem2A Patient Cable20102015-07-22
00856233005080EP ConnectTapcath8031-00012015-04-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00818087022873MAGiC SweepACCESS POINT TECHNOLOGIES, INC.DRF2026-05-15
00818087022880MAGiC SweepACCESS POINT TECHNOLOGIES, INC.DRF2026-05-15
00818087022897MAGiC SweepACCESS POINT TECHNOLOGIES, INC.DRF2026-05-15
00818087023054MAGiC SweepACCESS POINT TECHNOLOGIES, INC.DRF2026-05-15
00818087023061MAGiC SweepACCESS POINT TECHNOLOGIES, INC.DRF2026-05-15
00818087023085MAGiC SweepACCESS POINT TECHNOLOGIES, INC.DRF2026-05-15
00854277008135Vision-MR® Diagnostic CatheterImricor Medical Systems, Inc.DRF2026-05-06
04260192830601EasyMap MAP M (70mm)MedFact Engineering GmbHDRF2026-01-30
04260192832124EasyMap MAP L (80mm)MedFact Engineering GmbHDRF2026-01-30
04260192832131EasyMap MAP XL (90mm)MedFact Engineering GmbHDRF2026-01-30
24255650100406EasyConnect MAP CableMedFact Engineering GmbHDRF2026-01-30
00850012226000Axis Patient PatchesCardionxt IncDRF2025-12-10
00850012226154Multilink CS CatheterCardionxt IncDRF2025-12-10
00763000443214NAMEDTRONIC, INC.DRF2024-05-18
06952450942581EasyFinder Fixed Curve Diagnostic CatheterShanghai Microport Ep Medtech Co., Ltd.DRF2024-02-22
06952450942604EasyFinder Fixed Curve Diagnostic CatheterShanghai Microport Ep Medtech Co., Ltd.DRF2024-02-22
05414734202701Livewire™ST. JUDE MEDICAL CARDIOVASCULAR DIVISIONDRF2023-10-31
00763000445720NAMEDTRONIC, INC.DRF2023-03-18
10801902198379ARROWTELEFLEX INCORPORATEDDRF2022-11-17
10801902198348ARROWTELEFLEX INCORPORATEDDRF2022-10-28
10801902198256ARROWTELEFLEX INCORPORATEDDRF2022-10-21
10801902198317ARROWTELEFLEX INCORPORATEDDRF2022-10-17
10846835018080nGEN GeneratorBiosense Webster IncDRF2022-08-18
10801902211481ARROWTELEFLEX INCORPORATEDDRF2022-06-13
10801902211504ARROWTELEFLEX INCORPORATEDDRF2022-06-13
10801902198300ARROWTELEFLEX INCORPORATEDDRF2022-05-16
10801902198409ARROWTELEFLEX INCORPORATEDDRF2022-05-16
10801902198393ARROWTELEFLEX INCORPORATEDDRF2022-05-11
10801902004533ARROWTELEFLEX INCORPORATEDDRF2018-10-25
20801902004301ARROWTELEFLEX INCORPORATEDDRF2018-10-25