FDA.report

MIDWAY

Primary DI
00815948028197
Brand
MIDWAY
Company
PENUMBRA, INC.
Model
62MWAY115-A
Device description
MIDWAY 62 Delivery Catheter, 115cm, 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
QJPCatheter, Percutaneous, Neurovasculature

Product Code Classifications

CodeDeviceSpecialtyClass
QJPCatheter, Percutaneous, NeurovasculatureCardiovascular2

Premarket Submissions

SubmissionSupplement
K233201000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K233201000MIDWAY Delivery Catheter (MIDWAY 43 Delivery Catheter; MIDWAY 62 Delivery Catheter)Penumbra, Inc.2024-03-27QJP

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00815948028197PrimaryGS10

GMDN Terms

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.

Sterilization Methods

Method

Regulatory Flags

DUNS number
191077671
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
true
Sterilization required before use
false

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