FDA.reportPublic FDA data

Cruzar Medsystems Inc.

Primary DI
00860554000372
Brand
Cruzar Medsystems Inc.
Company
CRUZAR MEDSYSTEMS INC
Model
CM-3502
Device description
The Houdini Cross Support Catheter is a single use, bi-lumen intravascular catheter intended for percutaneous use.The Houdini Cross Support Catheter is intended to be used in conjunction with a steerable guidewire to access discrete regions of the peripheral vasculature and for guidewire exchange.
Published
2022-12-12
Public version status
Update
Distribution status
Not 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
DQYCatheter, Percutaneous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQYCatheter, PercutaneousCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860554000372PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860554000372008605540003728605540003720860554000372

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Balloon Diameter5Millimeter
Balloon Length2Centimeter
Catheter Gauge6French
Catheter Length115Centimeter
Catheter Working Length100Centimeter
Lumen/Inner Diameter0.018Inch
Pressure6Atmosphere

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080338871
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860554000303Cruzar Medsystems Inc.CM-36022022-12-12
00860554000327Cruzar Medsystems Inc.CM-37002016-08-26
00860554000334Cruzar Medsystems Inc.CM-34002016-08-26
00860554000358Cruzar Medsystems Inc.CM-38002016-08-26
00860554000365Cruzar Medsystems Inc.CM-35002016-08-26
00860554000396Cruzar Medsystems Inc.CM-36002016-08-26

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Primary DI, Brand, Company table
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