FDA.reportPublic FDA data

CardioCurve Steerable Sheath

Primary DI
10851498007272
Brand
CardioCurve Steerable Sheath
Company
CIRCA Scientific, Inc.
Model
CC-1071L
Published
2024-08-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
10851498007272PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1085149800727210851498007272

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. It is not intended solely for infusion nor to access superselective small vessels, and does not include a transseptal needle. A percutaneous introduction set, shaft visualization electrodes, or haemostatic valve may be supplied with the guide-catheter. This is a single-use device.

Regulatory Flags#

DUNS number
963223222
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
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
30860237000249S-CATH™ Esophageal Temperature ProbeCS-2001 (50cm Length)2016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10884450489854Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
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10884450489878Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
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10884450489892Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
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10884450495091Hydrophilic Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
10884450510602Prelude Prestige™Merit Medical Systems, Inc.DYB2026-09-22
10884450510640Prelude Prestige™Merit Medical Systems, Inc.DYB2026-09-22
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10801902227109ARROWTELEFLEX INCORPORATEDDYB2026-09-03
00884450840597Prelude Roadster™Merit Medical Systems, Inc.DYB2026-08-27
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10801902227246ARROWTELEFLEX INCORPORATEDDYB2026-08-27
10884450119836Prelude EASE™Merit Medical Systems, Inc.DYB2026-08-27