Transit Infusion Catheter with Sideholes

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

510(k) Number

K954949 ↗

FDA Product Code

KRA

Device Class

Class II

Regulation

21 CFR Part 870.1210

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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See all devices from Cordis Neurovascular, Inc. →

• What is the Transit Infusion Catheter with Sideholes used for?

  It is designed for infusion procedures in cardiovascular applications, facilitating fluid delivery through its sideholes during continuous flush catheter use.

• Is the Transit Infusion Catheter with Sideholes sterile or non-sterile, and is it intended for single use or reuse?

  The device is supplied as non-sterile and is intended for single-use only, as specified in its FDA 510(k) clearance documentation, to ensure patient safety and prevent cross-contamination.

• What regulatory pathway was used for the Transit Infusion Catheter with Sideholes, and what is its product code?

  It received FDA 510(k) clearance under K954949 with product code KRA, classified as substantially equivalent to a predicate device under regulation number 870.1210 for cardiovascular catheters.