Devices

Device Recall Dilator for percutaneous catheterization.

Model / Serial
Catalog Number MAK401, Lot Numbers: G322819, M9337627, MR314384, MR314386, MR317164, MR320056.
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide, including VA facilities in MA, MI, NY, RI and TX. Argentina, Canada, China, Germany, Italy, Israel, Netherlands, New Zealand, Saudi Arabia, Scotland, Singapore, Thailand, United Arab Emirates.
Product Description
Merit MAK Mini Access Kit, 4 French (1.3mm)
Manufacturer
Merit Medical Systems, Inc
1 Event
- Recall of Device Recall Dilator for percutaneous catheterization.

Manufacturer

Merit Medical Systems, Inc

Manufacturer Address
Merit Medical Systems, Inc, 1600 Merit Pkwy, South Jordan UT 84095-2416
Source
USFDA

2 devices with a similar name

Learn more about the data here

Device Recall Dilator for percutaneous catheterization.

Model / Serial
Catalog Number MAK401N, Lot Numbers: G331723, G338460, M9337635, MR314388, MR317166, MR320063.
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide, including VA facilities in MA, MI, NY, RI and TX. Argentina, Canada, China, Germany, Italy, Israel, Netherlands, New Zealand, Saudi Arabia, Scotland, Singapore, Thailand, United Arab Emirates.
Product Description
Merit MAK Mini Access Kit, 4 French (1.3mm)
Manufacturer
Merit Medical Systems, Inc

Device Recall Dilator for percutaneous catheterization.

Model / Serial
Catalog Number MAK405, Lot Numbers:G338462, M9337638, MR314387, MR317165, MR320060.
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide, including VA facilities in MA, MI, NY, RI and TX. Argentina, Canada, China, Germany, Italy, Israel, Netherlands, New Zealand, Saudi Arabia, Scotland, Singapore, Thailand, United Arab Emirates.
Product Description
Merit MAK Mini Access Kit, 4 French (1.3mm)
Manufacturer
Merit Medical Systems, Inc

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Disclaimer

Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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