Transit Infusion Catheter

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

510(k) Number

K952874 ↗

FDA Product Code

KRA

Device Class

Class II

Regulation

21 CFR Part 870.1210

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Prowler Select 10 and 14 Infusion Catheters with and Without Pre-Shaped Tips

  Class II

  FDA 510(k) K020680 Active Cleared 27 Mar 2002

• Trufill Dcs Syringe

  Class II

  FDA 510(k) K082324 Active Cleared 12 Sep 2008

• Essence Guidewire

  Class II

  FDA 510(k) K955637 Active Cleared 11 Mar 1996

• Agility Steerable Guidewire

  Class II

  FDA 510(k) K991646 Active Cleared 23 Sep 1999

• Trufill Dcs Orbit Detachable Coil System Line Extension

  Class II

  FDA 510(k) K053197 Active Cleared 15 Dec 2005

• Envoy Guiding Catheter

  Class II

  FDA 510(k) K965247 Active Cleared 23 Jul 1997

See all devices from Cordis Neurovascular, Inc. →

• What clinical settings is the Transit Infusion Catheter designed for, and how does it differ from standard catheters in those areas?

  The Transit Infusion Catheter is specifically designed for neurovascular and cardiovascular settings, where continuous infusion and flushing are critical. Unlike standard catheters, it is engineered to deliver fluids, medications, or contrast agents *directly into the bloodstream* while maintaining vascular access through continuous flushing. This dual function—infusion *and* patency maintenance—distinguishes it for procedures requiring precise, uninterrupted delivery, such as thrombolysis or diagnostic imaging in high-risk vascular areas.

• Is the Transit Infusion Catheter reusable, or is it intended for single-use only? What does this mean for my workflow?

  The Transit Infusion Catheter is intended for single-use only, as explicitly stated in its FDA 510(k) clearance. This means each catheter is sterile upon packaging and should not be reused or reprocessed. For your workflow, this simplifies infection control by eliminating the need for sterilization between patients, but you’ll need to account for inventory turnover and proper disposal protocols to ensure availability during procedures.

• How do I know which size or configuration of Transit Infusion Catheter to order, and are there multiple options available?

  The Transit Infusion Catheter comes in multiple sizes and configurations, as evidenced by the extensive list of FEI numbers (e.g., 3012543881, 3003495548, etc.) in the regulatory records. These variations likely correspond to differences in length, diameter, or tip design to accommodate diverse anatomical needs (e.g., cerebral arteries vs. peripheral vasculature). Consult your manufacturer’s product catalog or a representative to match the catheter’s specifications to your patient’s vascular anatomy and procedural requirements.

• Does the Transit Infusion Catheter require additional sterilization before use, or is it already sterile when received?

  The Transit Infusion Catheter is supplied sterile and does not require additional sterilization before use. This is confirmed by the manufacturer’s description and the device’s classification as sterile upon packaging. Always verify the sterility indicator (e.g., peel seal) is intact prior to opening to ensure sterility is maintained.

• What regulatory pathway was followed for the Transit Infusion Catheter’s clearance, and how does this affect its use in clinical practice?

  The Transit Infusion Catheter received FDA 510(k) clearance under product code KRA and regulation 870.1210, with a decision of *Substantially Equivalent* (SESE) to a predicate device. This traditional clearance pathway ensures the device meets safety and effectiveness standards for its intended use in neurovascular and cardiovascular applications. Clinically, this means the catheter is legally marketable in the U.S. for its described purposes, but always adhere to facility-specific protocols and manufacturer instructions for proper handling and use.