FDA.reportPublic FDA data

S-CATH M Mapping Interconnect Cable

Primary DI
00860237000293
Brand
S-CATH M Mapping Interconnect Cable
Company
CIRCA Scientific, Inc.
Model
CS-100
Published
2022-03-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
IKDCable, Electrode

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IKDCable, ElectrodePhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K200943000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200943000Circa S-Cath M Esophageal Temperature Probe and Temperature Monitoring SystemCirca Scientific, LLC2021-12-17FLL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860237000293PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860237000293008602370002938602370002930860237000293

GMDN Terms#

Term, Definition table
TermDefinition
Electrical-only medical device connection cable, reusableA non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
963223222
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10851498007197CardioCurve Steerable SheathCC-1040S2024-08-01
10851498007203CardioCurve Steerable SheathCC-1040M2024-08-01
10851498007210CardioCurve Steerable SheathCC-1040L2024-08-01
10851498007227CardioCurve Steerable SheathCC-1061S2024-08-01
10851498007234CardioCurve Steerable SheathCC-1061M2024-08-01
10851498007241CardioCurve Steerable SheathCC-1061L2024-08-01
10851498007258CardioCurve Steerable SheathCC-1071S2024-08-01
10851498007265CardioCurve Steerable SheathCC-1071M2024-08-01
10851498007272CardioCurve Steerable SheathCC-1071L2024-08-01
10851498007289CardioCurve Steerable SheathCC-1082S2024-08-01
10851498007296CardioCurve Steerable SheathCC-1082M2024-08-01
10851498007302CardioCurve Steerable SheathCC-1082L2024-08-01
10851498007463CrossWise RF Transseptal SystemCW-1010C2026-07-31
10851498007470CrossWise RF Transseptal SystemCW-1013A2026-07-31
10860237000207S-CATH™ Esophageal Temperature ProbeCS-27ST (Straight)2019-03-25
10860237000214S-CATH™ Esophageal Temperature ProbeCS-2001 (65cm Length)2016-09-23
10860237000238S-CATH™ Esophageal Temperature ProbeCS-2007 (65cm Length)2016-09-23
10860237000245S-CATH™ Esophageal Temperature ProbeCS-2001 (50cm Length)2016-09-23
30860237000218S-CATH™ Esophageal Temperature ProbeCS-2001 (65cm Length)2016-09-23
30860237000232S-CATH™ Esophageal Temperature ProbeCS-2007 (65cm Length)2016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06946725572283APKAPK Technology Co.,Ltd.IKD2026-09-04
04260223147760PATH ABR ElectrodesPATH medical GmbHIKD2026-08-25
00860004773733AtriAmp - Pacing CableAtrility Medical LLCIKD2026-08-18
06946725571736APKAPK Technology Co.,Ltd.IKD2026-08-15
06946725512173APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725513521APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725555262APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568439APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568446APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568453APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568460APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568477APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568484APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568491APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568507APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568514APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568521APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568538APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568545APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568552APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568569APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568576APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568705APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568859APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725569429APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725569436APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725569467APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725569474APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725570005APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725570142APKAPK Technology Co.,Ltd.IKD2026-08-14