FDA.report

RED 43

Primary DI
00815948028173
Brand
RED 43
Company
PENUMBRA, INC.
Model
RED43HFKIT153-A
Device description
Reperfusion Catheter RED 43 Kit, 153cm, 110 Tubing, no CE
Published
2024-04-02
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

Product Codes

CodeName
NRYCatheter, Thrombus Retriever

Product Code Classifications

CodeDeviceSpecialtyClass
NRYCatheter, Thrombus RetrieverCardiovascular2

Premarket Submissions

SubmissionSupplement
K222808000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K222808000Penumbra System (Reperfusion Catheter RED 43)Penumbra, Inc.2022-12-20NRY

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00815948028173PrimaryGS10

GMDN Terms

TermDefinition
Thrombectomy suction catheterA flexible or semi-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. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
191077671
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
true
Sterilization required before use
false

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