KENDALL INFANT ECMO VENOVENOUS CATHETER-DUAL LUMEN— 510(k) K895352

Clearance details

Applicant

Kendall Healthcare Products Co. Div.Of Tyco Health

Product code

Product code DWF

Device class

Class 2

Regulation

21 CFR 870.4210

Advisory panel

Cardiovascular

Date received

1989-09-01

Decision date

1989-11-29

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Mansfield, MA, US

• K263092 — Dual Stage Venous Cannulae2026-10-01
• K262052 — Tri Stage Venous Cannulae2026-09-28
• 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

• K973763 — KENDALL CURITY IODOFORM PACKING STRIP1997-12-31
• K973511 — KENDALL CURITY PETROLATUM GAUZE1997-12-16
• K973507 — KENDALL XEROFORM PETROLATUM DRESSING (6311,6312,6313,6314,6315,6316,6317)1997-12-15
• K973619 — KENDALL CURITY NON-ADHERING DRESSING1997-12-10
• K973509 — KENDALL CURASORB ZN + MG ALGINATE WOUND DRESSING1997-12-04

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 →