# P130005: Diamondback 360 Coronary Orbital Atherectomy System

- Pathway: PMA
- Applicant: Cardiovascular Systems, Inc.
- Decided: Oct 21, 2013 after 220 days
- Product code: MCX (Catheter, Coronary, Atherectomy)
- Device class: 3
- Recalls of this device: 2 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
1 of 1 device in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Recalls of this device
- Apr 13, 2018 · Class II · Z-3021-2018: The pumps may switch to stand-by during use requiring the pump to be reset prior to continuing treatment.
- Mar 4, 2015 · Class I · Z-1290-2015: The OAD saline sheath outer layer may flake off from the catheter due to friction between the outer material layer and corresponding materials it may come in contact with during clinical use. If the m

Source page: https://510kreport.com/device/P130005
Methodology: https://510kreport.com/methodology