# P900056: Rotablator (R)

- Pathway: PMA
- Applicant: Boston Scientific Corp
- Decided: May 28, 1993 after 1,004 days
- Product code: MCX (Catheter, Coronary, Atherectomy)
- Device class: 3
- Recalls of this device: 4 (2 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
- Mar 8, 2022 · Class II · Z-0915-2022: Pouch seals may be open, compromising sterility.
- Mar 8, 2022 · Class II · Z-0916-2022: Pouch seals may be open, compromising sterility.
- Oct 9, 2015 · Class I · Z-0211-2016: Boston Scientific is recalling its recently released RotaWire Elite Guidewire and wireClip Torquer Guidewire Manipulation device that is used in conjunction with the Rotablator Rotational Atherectomy 
- Oct 9, 2015 · Class I · Z-0212-2016: Boston Scientific is recalling its recently released RotaWire Elite Guidewire and wireClip Torquer Guidewire Manipulation device that is used in conjunction with the Rotablator Rotational Atherectomy 

Source page: https://510kreport.com/device/P900056
Methodology: https://510kreport.com/methodology