Localmed Infusion Catheter

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

510(k) Number

K935349 ↗

FDA Product Code

KRA

Device Class

Class II

Regulation

21 CFR Part 870.1210

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Infusasleeve Iia (Is-2A)

  Class II

  FDA 510(k) K972175 Active Cleared 28 Aug 1997

• Kaplan-Simpson Infusasleeve Catheter

  Class II

  FDA 510(k) K950615 Active Cleared 19 Apr 1995

• Kaplan-Simpson Infusasleeve II

  Class II

  FDA 510(k) K980957 Active Cleared 10 Jun 1998

• Kaplan-Simpson InfusaSleeve II Catheter

  Class II

  FDA 510(k) K952317 Active Cleared 28 Jun 1995

• What is the Localmed Infusion Catheter primarily used for in clinical settings?

  The Localmed Infusion Catheter is designed for continuous intravascular flushing during cardiovascular procedures. It helps prevent clotting, back-leakage, and waveform damping by maintaining a slow infusion rate within the vascular system, ensuring accurate pressure monitoring and fluid dynamics.

• Is the Localmed Infusion Catheter intended for single-use or reusable applications?

  The Localmed Infusion Catheter is explicitly intended for single-use in clinical settings, as stated in its description and regulatory documentation.

• How is the Localmed Infusion Catheter supplied, and what does that mean for handling?

  The device is supplied sterile, meaning it is pre-sterilized and packaged to prevent contamination before use. This ensures it can be safely inserted without additional sterilization steps, but users must follow manufacturer guidelines to maintain sterility during handling and deployment.

• Are there multiple sizes or configurations available for the Localmed Infusion Catheter?

  Yes, the Localmed Infusion Catheter comes in multiple variations, as indicated by the numerous FEI numbers (e.g., 3012543881, 3003495548) listed in the data. While specific dimensions are not detailed, these identifiers likely correspond to different sizes or configurations tailored for various clinical applications.

• What regulatory pathway was followed for the Localmed Infusion Catheter’s FDA clearance?

  The Localmed Infusion Catheter received FDA 510(k) clearance (K935349) under the traditional review pathway, classified as a Class II medical device. It was reviewed by the Cardiovascular (CV) Advisory Committee and determined to be substantially equivalent to a predicate device, as noted in the decision description.