SMEC Balloon Cannula

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K790755 ↗

FDA Product Code

DSP

Device Class

Class II

Regulation

21 CFR Part 870.3535

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Intra-Aortic Balloon System

  Class II

  FDA 510(k) K823739 Active Cleared 18 Feb 1983

• Smec Balloon System

  Class II

  FDA 510(k) K823177 Active Cleared 15 Dec 1982

• Modified Smec Percutaneous Intra-Aortic

  Class II

  FDA 510(k) K840037 Active Cleared 1 Feb 1985

• Modification of the Percutan-Balloon

  Class II

  FDA 510(k) K813355 Active Cleared 2 Jul 1982

• Pressure Trigger Mod of Smec Intra-Aort

  Class II

  FDA 510(k) K840367 Active Cleared 11 Dec 1985

• Percutaneous Balloon

  Class II

  FDA 510(k) K832753 Active Cleared 13 Oct 1984

• What is the SMEC Balloon Cannula used for?

  The SMEC Balloon Cannula is a system, balloon, intra-aortic and control device designed for use in cardiovascular procedures with balloon pumps. It is classified as a Class II medical device manufactured by Smec, Inc.

• Is the SMEC Balloon Cannula single-use or reusable?

  The SMEC Balloon Cannula is supplied as either a single-use or reusable product depending on the specific model selected. The manufacturer offers different configurations to meet various clinical needs.

• What sizes and models are available for the SMEC Balloon Cannula?

  The SMEC Balloon Cannula is available in various sizes and models, including model K790755. This variety allows clinicians to select the appropriate device for different patient anatomies and procedural requirements.

• What is the regulatory status of the SMEC Balloon Cannula?

  The SMEC Balloon Cannula received FDA 510(k) clearance on May 14, 1980, with product code DSP. It is regulated under 870.3535 and is classified as a Class II medical device for cardiovascular procedures.