# P950020: Flexatome Cutting Balloon

- Pathway: PMA
- Applicant: Boston Scientific Corp
- Decided: Apr 18, 2000 after 1,758 days
- Product code: NWX (Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring)
- Device class: 3
- Recalls of this device: 6 (0 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.
0 of 1 device in its family (counting itself) have 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
- Jul 31, 2013 · Class II · Z-2137-2013: Boston Scientific is initiating a recall removal of the 4.0mm x 15mm size of Small Peripheral Cutting Balloon (Monorail and Over-the-Wire) Microsurgical Dilatation Devices and Flextome Cutting Balloon
- Jul 31, 2013 · Class II · Z-2138-2013: Boston Scientific is initiating a recall removal of the 4.0mm x 15mm size of Small Peripheral Cutting Balloon (Monorail and Over-the-Wire) Microsurgical Dilatation Devices and Flextome Cutting Balloon
- Nov 21, 2008 · Not classified · Z-0621-2009: For one batch/lot of flextome Cutting Balloon (OTW), an incorrect compliance chart was packaged inside the sterile pouch. For the affected batch/lot, the compliance chart packed inside the pouch of th
- Jul 21, 2006 · Not classified · Z-1512-06: Lack of assurance of sterility (pre-sterilization bioburden limits exceeded)
- Dec 7, 2005 · Not classified · Z-0409-06: The distal shaft of the catheter may separate during withdrawal of the device from the patient. If the shaft separates, the surgical procedure may be prolonged or require more in-depth surgery to phys
- Dec 7, 2005 · Not classified · Z-0410-06: The distal shaft of the catheter may separate during withdrawal of the device from the patient. If the shaft separates, the surgical procedure may be prolonged or require more in-depth surgery to phys

Source page: https://510kreport.com/device/P950020
Methodology: https://510kreport.com/methodology