Venture Infusion Catheter

No FDA recalls on record, checked 22 Oct 2026.

Full name

Scimed(R) Venture(Tm) Infusion Catheter

510(k) Number

K931335 ↗

FDA Product Code

KRA

Device Class

Class II

Regulation

21 CFR Part 870.1210

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Triguide Guide Catheters

  Class II

  FDA 510(k) K953515 Active Cleared 19 Sep 1995

• Scimed Viper

  Class II

  FDA 510(k) K933183 Active Cleared 9 Sep 1993

• Scimed 7Fr and 8Fr Triguide Guiding Catheters

  Class II

  FDA 510(k) K914312 Active Cleared 22 Nov 1991

• Scimed Triguide Guide Catheter

  Class II

  FDA 510(k) K944537 Active Cleared 21 Oct 1994

• Scimed Pursuit Exchange Ptca Guide Wire

  Class II

  FDA 510(k) K945159 Active Cleared 30 Dec 1994

• Scimed(R) Controlwire(Tm) Guide Wire

  Class II

  FDA 510(k) K914194 Active Cleared 9 Jun 1992

See all devices from Scimed Life Systems, Inc. →

• What clinical settings is the Venture Infusion Catheter primarily designed for, and why is this important for clinicians?

  The Venture Infusion Catheter is designed for use in cardiovascular settings, including intensive care units (ICUs) and operating rooms. This is important because these environments require reliable vascular access for continuous administration of fluids, medications, or blood products while minimizing the risk of occlusion—a critical concern in critical care and surgical contexts.

• Is the Venture Infusion Catheter compatible with MRI environments, and if so, how does this benefit patients?

  Yes, the Venture Infusion Catheter is specifically compatible with MRI environments when used as intended. This compatibility is beneficial for patients who may require both vascular access and MRI imaging (e.g., for diagnostic or monitoring purposes) without the need to discontinue or replace the catheter, reducing disruption to their care.

• Are there multiple sizes or configurations available for the Venture Infusion Catheter, and how does this affect its versatility?

  Yes, the Venture Infusion Catheter comes in multiple sizes and configurations, as indicated by the associated FEI numbers (e.g., 3012543881, 3003495548, etc.). This variety allows clinicians to select the most appropriate catheter for different patient anatomies, vascular access points, or clinical needs, enhancing its versatility across diverse cardiovascular procedures.

• How should the Venture Infusion Catheter be stored to maintain its sterility and functionality, and why is this important?

  The Venture Infusion Catheter must be stored according to manufacturer guidelines to preserve sterility and functionality. Since it is a single-use, sterile product, improper storage (e.g., exposure to moisture, contamination, or extreme temperatures) could compromise its integrity before use. Proper storage ensures the catheter remains safe and effective for its intended purpose when opened for clinical use.

• What regulatory pathway was followed for the Venture Infusion Catheter, and what does this mean for its use in clinical practice?

  The Venture Infusion Catheter followed the FDA 510(k) Traditional pathway, with a substantially equivalent (SESE) determination by the Cardiovascular (CV) Advisory Committee. This means the device was reviewed for safety and effectiveness compared to a legally marketed predicate, ensuring it meets FDA standards for Class II medical devices under regulation 870.1210. Clinically, this indicates the catheter has undergone rigorous evaluation to support its use in vascular access for continuous infusion.