Infus. SETS-9120-50 CM & 9121-100 CM, Ext

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

510(k) Number

K822775 ↗

FDA Product Code

FPA

Device Class

Class II

Regulation

21 CFR Part 880.5440

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Acuity Universal Cutter

  Class II

  FDA 510(k) K080154 Active Cleared 20 Mar 2008

• Pacemaker Programmer #2010

  Class III

  FDA 510(k) K811217 Active Cleared 20 Jul 1981

• Microthin-Pii Bipolar Pulse Gen. #0623

  Class III

  FDA 510(k) K803034 Active Cleared 22 Dec 1980

• Astra 2, 3, 4 and 6: Chip Revision

  Not classified

  FDA 510(k) K863000 Active Cleared 19 Aug 1986

• Command Ultra I Implantable Pacemaker Pulse-Generator

  Class III

  FDA 510(k) K831161 Active Cleared 15 Jun 1983

• Elgiloy Stylet

  Class II

  FDA 510(k) K770243 Active Cleared 14 Feb 1977

See all devices from Cardiac Pacemakers, Inc. →

• What lengths are offered for the INFUS. SETS model?

  The product line includes two lengths: a 50 cm set (model 9120) and a 100 cm set (model 9121). Offering both options lets clinicians select the appropriate tubing length for the specific procedure or patient anatomy.

• Are the infusion sets supplied sterile and intended for reuse?

  Yes, each set is supplied sterile to ensure aseptic use, but they are designated for single‑use only. Single‑use packaging prevents cross‑contamination and maintains performance standards for each patient.

• How should the infusion sets be stored before use?

  The sets must be kept in a dry environment. Moisture can compromise the sterile barrier and affect the integrity of the tubing, so dry storage preserves their safety and functionality.

• Can these infusion sets be used in an MRI suite?

  No, the devices are not MRI safe. The materials or construction could be affected by the magnetic field, posing a risk to patient safety and device performance during MRI scanning.

• What regulatory clearance does this device have?

  The infusion sets received FDA 510(k) clearance (K822775) under a traditional review, indicating they are substantially equivalent to a legally marketed predicate device.