Devices

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.
Manufacturer
Cardiovascular Systems, Inc.
1 Event
- Recall of Diamondback 360 Orbital Atherectomy Device

Manufacturer

Cardiovascular Systems, Inc.

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

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