Devices

Device Recall Prelude Pro Sheath Introducter

Model / Serial
Catalo Number PR0-6F-11-038, Lot Number H767887
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution - US including TN, NE, MA, SC, WI, UT and Internationally to Belgium, Switzerland, United Kingdom, and Germany.
Product Description
Merit Medical Prelude Pro Sheath Introducter, 6F (2.0mm) 11cm, REF PRO-6F-11-038, Sterile EO || The Merit Prelude Sheath Introducer is intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures.
Manufacturer
Merit Medical Systems, Inc.
1 Event
- Recall of Device Recall Prelude Pro Sheath Introducter

Manufacturer

Merit Medical Systems, Inc.

Manufacturer Address
Merit Medical Systems, Inc., 1600 West Merit Parkway, South Jordan UT 84095
Manufacturer Parent Company (2017)
Merit Medical Systems Inc
Source
USFDA

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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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