FDA.report

PRONTO

Primary DI
20841156109001
Company
TELEFLEX INCORPORATED
Model
IPN922587
Catalog number
5015
Device description
PRONTO LP 5F
Published
2021-09-15
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
002348191
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

Identifiers

IdentifierTypeAgencyPackage quantityStatus
20841156109001PackageGS11In Commercial Distribution
10841156109004PrimaryGS10

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityPackage typeContains DIDiscontinue dateStatus
20841156109001PackageGS11Box10841156109004In Commercial Distribution
10841156109004PrimaryGS10

Product Codes

CodeNameClassSpecialtyRegulationImplantMalfunction reporting
QEZAspiration Thrombectomy Catheter2Cardiovascular870.5150NEligible

Premarket Submissions

No records found.

Premarket Details

No records found.

GMDN Terms

TermDefinition
Thrombectomy suction catheterA sterile flexible tube designed for the percutaneous, transluminal disruption and removal of clotted blood (i.e., a thrombus or thromboembolus) or other formed elements causing vascular obstruction in native and stented blood vessels, native and synthetic bypass grafts, and/or haemodialysis access grafts, through suction (aspiration) typically achieved with the use of an included syringe(s) attached to the proximal end of the catheter, or connection to a dedicated suction pump system. Collection baskets may also be included to obtain filtered blood specimens for analyses. This is a single-use device.

Device Sizes

TypeValueText
Catheter Gauge5 French

Storage And Handling

No records found.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(919)544-8000CS@TELEFLEX.COM

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