EDM(R) Infusion Catheter

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

510(k) Number

K914979 ↗

FDA Product Code

KRA

Device Class

Class II

Regulation

21 CFR Part 870.1210

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Balloon Dilatation Catheter

  Class II

  FDA 510(k) K894944 Active Cleared 19 Jan 1990

• Smartneedle(Tm) Vascular Access System

  Class II

  FDA 510(k) K913746 Active Cleared 17 Dec 1991

• PSG EDM Infusion Catheter

  Class II

  FDA 510(k) K895932 Active Cleared 4 Jan 1990

• Doppler Needle and Flow Monitor

  Class II

  FDA 510(k) K903625 Active Cleared 7 Nov 1990

• Guiding Catheter

  Class II

  FDA 510(k) K895146 Active Cleared 19 Jan 1990

• Smartneedle(R) Over-the-Needle Catheter

  Class II

  FDA 510(k) K932777 Active Cleared 7 Oct 1993

See all devices from Peripheral Systems Group →

• What is the EDM(R) Infusion Catheter used for?

  This device is a Catheter, Continuous Flush intended for use in cardiovascular procedures.

• Is the EDM(R) Infusion Catheter sterile and for single use?

  Yes, the device is supplied sterile and is intended for single use only.

• Is the EDM(R) Infusion Catheter MRI safe?

  No, the EDM(R) Infusion Catheter is not MRI safe.

• How is the EDM(R) Infusion Catheter regulated?

  The EDM(R) Infusion Catheter is regulated under FDA 510(k) clearance, K914979.