COBE HEART/LUNG PERFUSION AND CARDIOPLEGIA PACK— 510(k) K881330

Name: FDA 510(k) clearance K881330
Creator: U.S. Food and Drug Administration
Published: 1988-06-10

Substantially Equivalent

Cobe Laboratories, Inc.

FDA 510(k) clearance K881330 for COBE HEART/LUNG PERFUSION AND CARDIOPLEGIA PACK, Substantially Equivalent on 1988-06-10. Applicant: Cobe Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Cobe Laboratories, Inc.
Product code: Code DWF
Device class: Class 2
Regulation: 21 CFR 870.4210
Advisory panel: Cardiovascular
Date received: 1988-03-29
Decision date: 1988-06-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lakewood, CO, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DWF

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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

More clearances from Cobe Laboratories, Inc.

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K923272 — COBE CMS-HF HOLLOW FIBER MEMBRANE OXYGENATOR1993-05-11
K900105 — COBE SPECTRA BLOOD COMPONENT SEPARATOR THERAPEUTIC1991-03-22
K905793 — COBE CENTRY 2 BICART OPTION KIT1991-02-12
K905388 — COBE CENTRYSYSTEM 3 BICART OPTION KIT1991-02-11
K904336 — NEW COBE SATURATION/HEMATOCRIT MONITOR1990-12-27

Adverse events under product code DWF

product code DWF

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 →

Recalls naming K881330

K-number listed on FDA's recall record

Z-0770-2019 — Perfusion Pack, Rx only, Sterile EOClass II·Terminated·LivaNova USA·20181109
Z-1018-2016 — CDI H/S Cuvette, non-sterile, Manufactured by Terumo Cardiovascular Group, Perfusion Pack or Smart Perfusion Pack. Product Usage: Heart/Lung Perfusion Pack is either a customized tubing pack built to user specifications or a stock tubing pack, designed for use during surgery requiring cardiopulmonary bypass. It is not designed for long-term use (greater than six hours). Perfusion Packs labeled as SMART¿ contain components that have an additive to improve blood compatibility. Non-SMART packs may contain some SMART tubing and/or connectors depending on the customer requirements.Class III·Terminated·Sorin Group USA, Inc.·20160119
Z-1985-2013 — Edwards Lifesciences Suction Wand Model S099B, packaged in Sorin Group Heart/Lung Perfusion Packs.Class II·Terminated·Sorin Group USA, Inc.·20130708

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K881330.

Data sourced from openFDA. This site is unofficial and independent of the FDA.