Hypertransit Infusion Catheter

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

Full name

Modification to Hypertransit Infusion Catheter

510(k) Number

K070279 ↗

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 types of vascular procedures is the Hypertransit Infusion Catheter designed to support, and how does it differ from standard catheters in this context?

  The Hypertransit Infusion Catheter is specifically designed for selective infusion of diagnostic and embolic agents in coronary, neuro, and peripheral vasculature, as well as for guidewire exchange and superselective angiography of peripheral and coronary vessels. Unlike standard catheters, it is engineered to facilitate precise vascular interventions by enabling targeted delivery of substances while maintaining flexibility for catheter navigation and imaging.

• Is the Hypertransit Infusion Catheter intended for reuse, or is it meant to be used only once per patient?

  The device is explicitly intended for single-use only in clinical settings. This is standard practice for infusion catheters to ensure sterility and patient safety, particularly in procedures involving sensitive vasculature like coronary or neurovascular systems.

• How is the Hypertransit Infusion Catheter supplied, and what should clinicians verify before use?

  The catheter is supplied sterile and ready for immediate use in cardiovascular procedures. Clinicians should verify the sterility seal is intact and confirm the correct model/size (if applicable) matches their procedural requirements, as the data does not specify variable sizing but implies compatibility with multiple vascular access points.

• What regulatory pathway was followed for this modification to the Hypertransit Infusion Catheter, and what does that mean for its use?

  The modification received FDA 510(k) clearance (K070279) under the Special 510(k) Review pathway, classified under Regulation 870.1210 and reviewed by the Cardiovascular (CV) Advisory Committee. This means the device was determined to be substantially equivalent to a legally marketed predicate, ensuring it meets FDA safety and effectiveness standards for use in cardiovascular procedures.