FDA.report

Mighty Wire™

Primary DI
20884450564015
Brand
Mighty Wire™
Company
Merit Medical Systems, Inc.
Model
Initial Release
Catalog number
MW351807S
Published
2024-08-13
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
DQXWire, guide, catheter

Product Code Classifications

CodeDeviceSpecialtyClass
DQXWire, Guide, CatheterCardiovascular2

Premarket Submissions

SubmissionSupplement
K230418000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K230418000Mighty Wire Guide WireMerit Medical Systems, Inc.2023-10-28DQX

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10884450564018PackageGS15In Commercial Distribution
20884450564015PackageGS110In Commercial Distribution
00884450564011PrimaryGS10

GMDN Terms

TermDefinition
Cardiac/peripheral vascular guidewire, single-useA long, thin, sterile wire intended to be percutaneously placed into the cardiac vasculature (ventricles or coronary vessels) to function as a guide for the introduction, positioning, and/or operation of a device (e.g., catheter, pacing lead); it may also be used in the peripheral vasculature. It may be made of metal (e.g., stainless steel, Nitinol), or polymer and/or glass materials to provide MRI-compatibility, with or without coating, and is available in a variety of distal tip designs. It is used for various diagnostic and interventional procedures, and may include devices used to facilitate manipulation (e.g., torque device). This is a single-use device.

Device Sizes

TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0

Sterilization Methods

Method

Regulatory Flags

DUNS number
184763290
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

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