FDA.report

Biosensors Embolectomy Catheter

Primary DI
08886483507517
Company
BIOPTIMAL INTERNATIONAL PTE. LTD.
Model
EL3280
Catalog number
EC-0001-002
Published
2020-10-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Regulatory Flags

DUNS number
595182247
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Identifiers

IdentifierTypeAgencyPackage quantityStatus
08886483507517PrimaryGS10

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityPackage typeContains DIDiscontinue dateStatus
08886483507517PrimaryGS10

Product Codes

CodeNameClassSpecialtyRegulationImplantMalfunction reporting
DXECatheter, Embolectomy2Cardiovascular870.5150NEligible

Premarket Submissions

No records found.

Premarket Details

No records found.

GMDN Terms

TermDefinition
Thrombectomy balloon catheterA sterile flexible tube designed for the percutaneous, transluminal disruption and removal of clotted blood (i.e., a thrombus or thromboembolus) causing vascular obstruction in native and stented blood vessels, native and synthetic bypass grafts, and/or haemodialysis access grafts, through distension of a balloon intended to dilate the stenosis. It is a balloon catheter that may include valves for the injection of contrast media/thrombolytic agents and/or an embolectomy coil for mechanical removal of the obstruction. This is a single-use device.

Device Sizes

No records found.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Store in dark cool dry places

Sterilization Methods

Method

Contacts

PhoneEmail
+6562135777Sales_CCP@biosensors.com

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