FDA.report

PRONTO

Primary DI
30841156100319
Company
TELEFLEX INCORPORATED
Model
IPN913539
Catalog number
5010
Device description
Pronto LP, 6F
Published
2018-10-01
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

Related Records

Regulatory Flags

DUNS number
002348191
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
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
30841156100319PackageGS11In Commercial Distribution
10841156100315PrimaryGS10

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityPackage typeContains DIDiscontinue dateStatus
30841156100319PackageGS11Box10841156100315In Commercial Distribution
10841156100315PrimaryGS10

Product Codes

CodeNameClassSpecialtyRegulationImplantMalfunction reporting
DXECatheter, Embolectomy2Cardiovascular870.5150NEligible

Premarket Submissions

No records found.

Premarket Details

No records found.

GMDN Terms

TermDefinition
Thrombectomy suction catheterA 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/stented blood vessels, native/synthetic bypass grafts, and/or haemodialysis access grafts, through suction (aspiration) in conjunction with a syringe or dedicated suction pump system (pump not included). It may additionally be intended for infusion of fluids and/or used as a guide-catheter to facilitate introduction of a thrombectomy wire-net (not included) to remove residual thrombus. Collection containers may be included with the catheter to obtain blood samples. This is a single-use device.

Device Sizes

TypeValueText
Catheter Gauge6 French

Storage And Handling

No records found.

Sterilization Methods

Method

Contacts

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

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