PTA Balloon Catheter

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K915349 ↗

FDA Product Code

LIT

Device Class

Class II

Regulation

21 CFR Part 870.1250

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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See all devices from Schneider Intl., Ltd. →

• What is the PTA Balloon Catheter used for?

  The PTA Balloon Catheter is used for percutaneous transluminal angioplasty (PTA) to dilate narrowed or obstructed peripheral arteries in cardiovascular applications, as indicated in its labeling and clearance documentation.

• How is the PTA Balloon Catheter supplied and sterilized?

  The device is supplied by Schneider Intl., Ltd., but sterility is not specified in the provided data; users must refer to the manufacturer’s instructions for use to determine sterility status, reuse limitations, and storage requirements.

• What regulatory pathway was used for the PTA Balloon Catheter?

  The PTA Balloon Catheter was cleared via the FDA 510(k) process under submission K915349 with a traditional clearance, based on a finding of substantial equivalence to a predicate device.