USCI Probe III Balloon-on-a-Wire Dilatation System

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

Full name

Usci(R) Probe III(Tm) Balloon-on-a-Wire(Tm) D. Sys

Trade Name

Usci Probe III Balloon-on-a-Wire Dilatation System

Generic Name

Catheters, transluminal coronary angioplasty, percutaneous

PMA Number

P890048 ↗

FDA Product Code

LOX

Device Class

Class II

Regulation

21 CFR Part 870.5100

Advisory Committee

Cardiovascular

FDA Decision

APRL

• Catheter, Percutaneous Introduc. & Sheath

  Class II

  FDA 510(k) K770561 Active Cleared 26 Apr 1977

• Catheter, Cardiovascular

  Class II

  FDA 510(k) K771823 Active Cleared 20 Dec 1977

• Sauvage Filamentous Prostheses

  Class II

  FDA 510(k) K770236 Active Cleared 25 Feb 1977

• Paley Transparent Manifold

  Class II

  FDA 510(k) K760843 Active Cleared 12 Nov 1976

• 888 Arterial/Venous Catheter Introducer

  Class II

  FDA 510(k) K771982 Active Cleared 2 Nov 1977

• Patch Fabric

  Class II

  FDA 510(k) K770835 Active Cleared 5 Oct 1977

See all devices from Usci, Div. C.R. Bard, Inc. →

• What is the USCI Probe III Balloon-on-a-Wire Dilatation System used for?

  The USCI Probe III Balloon-on-a-Wire Dilatation System is a catheter designed for coronary artery dilation. It features a balloon-tipped wire system intended to mechanically widen narrowed or obstructed coronary arteries during percutaneous coronary intervention (PCI).

• How is the USCI Probe III Balloon-on-a-Wire Dilatation System supplied?

  The device is supplied as a single-use, non-sterile system. It is classified under FDA Product Code LOX and is intended for use in cardiac catheterization laboratories by trained interventional cardiologists.

• Is the USCI Probe III Balloon-on-a-Wire Dilatation System reusable?

  No, the USCI Probe III Balloon-on-a-Wire Dilatation System is supplied as a single-use system and is not designed for reuse.

• What is the regulatory status of the USCI Probe III Balloon-on-a-Wire Dilatation System?

  The USCI Probe III Balloon-on-a-Wire Dilatation System has an FDA Premarket Approval (PMA P890048). It is classified under FDA Product Code LOX and is intended for use in cardiac catheterization laboratories by trained interventional cardiologists.