INTRACARDIA SUCKERS— 510(k) K831759

Clearance details

Applicant

Research Industries Corp.

Product code

Code DWF

Device class

Class 2

Regulation

21 CFR 870.4210

Advisory panel

Cardiovascular

Date received

1983-06-01

Decision date

1983-08-12

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Walker, MI, US

• K260195 — Elongated One-Piece Arterial (EOPA) 3D Arterial Cannulae2026-04-23
• K250937 — Venous Return Cannulae2026-03-11
• K260043 — Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR180C)2026-02-23
• K253203 — Retrograde Coronary Sinus Perfusion Cannulae2026-02-19
• K253671 — Dual Stage Venous Cannulae2026-01-30

• K945931 — RMI CIRKUIT-GUARD(TM) PRESSURE RELIEF VALVE1995-03-03
• K833433 — PHYSIO-PROBE-HIGH PERMEABILITY CATH.1983-12-29
• K832542 — I.V. ADMINISTRATION SET1983-10-31
• K831769 — VARIOUS CARDIOVASCULAR SURGICAL DEVICE1983-08-12

Death

106

Injury

386

Malfunction

2,323

Total

2,815

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-1749-2013 — Edwards Lifesciences Suction Wand, models S099 and S0998B Suction wands are intended for hand held use and pericardial sumps are intended for stationary use in removing excess fluid from the surgical field.Class II·Terminated·Edwards Lifesciences, LLC·20130619
• Z-1967-2012 — Edwards Lifesciences Rigid Suction Wand, sterile. Model numbers S033 and SPC2081. Product Usage: These suction catheters are typically used to remove fluid on the external surface of the heart during cardiac surgery and therefore there is little risk of intravascular involvement.Class II·Terminated·Edwards Lifesciences, LLC·20120606

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K831759.