FDA.reportPublic FDA data

CardioCurve Steerable Sheath

Primary DI
10851498007241
Brand
CardioCurve Steerable Sheath
Company
CIRCA Scientific, Inc.
Model
CC-1061L
Published
2024-08-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DYBIntroducer, Catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYBIntroducer, CatheterCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10851498007241PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1085149800724110851498007241

GMDN Terms#

Term, Definition table
TermDefinition
Vascular guide-catheter, single-useA flexible tube intended to be used for the percutaneous transluminal passage and placement of a diagnostic/interventional catheter, lead (e.g., pacing lead, balloon dilatation catheter), needle or guidewire through its lumen(s), within the vascular system. It may be rigid or flexible, non-steerable or steerable, single or multiple lumen(s), and the distal section can have a variety of preformed shapes (e.g., straight, hockey stick). It is not intended solely for infusion, is not intended to access superselective small vessels, and does not include a transseptal needle. It may include a disposable percutaneous introduction set or shaft visualization electrodes. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
30860237000249S-CATH™ Esophageal Temperature ProbeCS-2001 (50cm Length)2016-09-23
10851498007395PeriCross Epicardial Access KitPC-10132025-07-23
10851498007432CrossWise RF Transseptal SystemCW-1085C2025-05-28
10851498007449CrossWise RF Transseptal SystemCW-1085V2025-05-28
10851498007456CrossWise RF Transseptal SystemCW-1013F2025-05-28
00851498007404CIRCA Temperature Monitoring SystemCS-1000 (SW Ver 3.2)2025-02-14
10851498007333CrossWise RF Transseptal SystemCW-1085S2024-12-02
10851498007340CrossWise RF Transseptal SystemCW-1085A2024-12-02
10851498007357CrossWise RF Transseptal SystemCW-1012W2024-12-02
10851498007364CrossWise RF Transseptal SystemCW-1012C2024-12-02
10851498007371CrossWise Multi-Use RF Adapter CableCW-10012024-12-02
00851498007381CIRCA Temperature Monitoring SystemCS-1000 (SW Ver 3.1)2024-10-31

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10801902193114ARROWTELEFLEX INCORPORATEDDYB2026-07-30
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00850084947001Genie MAXCULTIV8 1, LLCDYB2026-05-29
G440VIZ1750MultiflexVizaramed, Inc.DYB2026-04-09
04251244502768Catapult Guide SheathContract Medical International GmbHDYB2024-08-19
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