Devices

ProLumen Rotational Thrombectomy System. Catalog No. 86311, sold as a single unit packaged in a shelf carton.

Model / Serial
Lot Numbers--Exp.Date: M354580 -- 2004-03; M357300-- 2004-05; M401160-- 2004-08; M401170 -- 2004-08; M413790 --2004-09; M414240 -- 2004-09; M437260 -- 2004-10.
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
The product was shipped nationwide to 243 direct accounts. and to 7 government accounts.
Product Description
ProLumen Rotational Thrombectomy System. Catalog No. 86311, sold as a single unit packaged in a shelf carton.
Manufacturer
Datascope Interventional Products Division
1 Event
- Recall of ProLumen Rotational Thrombectomy System. Catalog No. 86311, sold as a single unit packaged in a shelf carton.

Manufacturer

Datascope Interventional Products Division

Manufacturer Address
Datascope Interventional Products Division, 1300 Macarthur Blvd, Mahwah NJ 07430
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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