International Medical Devices Database

Manufacturer Address
Cardiovascular Systems, Inc., 651 Campus Dr, Arden Hills MN 55112-3495
Manufacturer Parent Company (2017)
Cardiovascular Systems Inc.
Source
USFDA
2 Events
- Recall of Device Recall Diamondback 360, CSI ViperWire
- Recall of Diamondback 360 Orbital Atherectomy Device

2 devices in the database

Device Recall Diamondback 360, CSI ViperWire

Model / Serial
Lot: P1406641
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide Distribution
Product Description
Diamondback 360, CSI ViperWire Orbital Atherectomy Guide Wire, REF: GW14335FRM. Sterilized with Ethylene Oxide. Manufactured for Cardiovascular Systems, Inc., St. Paul, MN 55112, USA. The ViperWire atherectomy guide wire has a shaft diameter of 0.014" and is constructed of stainless steel with a smooth finish and is silicone coated. The spring tip configuration is atraumatic, radiopaque, and can be bent to form a steerable system.

Diamondback 360 Orbital Atherectomy Device

Model / Serial
Lot Number: 23181.
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide Distribution -- CA, GA, MI, NY, NY and TN.
Product Description
Diamondback 360 Orbital Atherectomy Device, 1.50 LT Classic, Model #DB-150L, CSI Part # 70025-02 || Expiration 2012-02, Sterilized with Ethylene Oxide , Cardiovascular Systems, Inc., St. Paul, MN USA. || The Diamondback 360 OAD are used with CSI's orbital atherectomy system in patients with arterial disease.

One manufacturer with a similar name

Learn more about the data here

Cardiovascular Systems, Inc.

Manufacturer Address
Cardiovascular Systems, Inc., 651 Campus Dr, Saint Paul MN 55112-3495
Manufacturer Parent Company (2017)
Cardiovascular Systems, Inc.
Source
USFDA

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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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