EXTRACORP.'S INTERSEPT CUS. TUBING PK.— 510(k) K800178

Clearance details

Applicant

Extracorporeal Medical Specialities, Inc.

Product code

Code DWE

Device class

Class 2

Regulation

21 CFR 870.4390

Advisory panel

Cardiovascular

Date received

1980-01-28

Decision date

1980-02-21

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Walker, MI, US

• K233702 — SMARxT Tubing and Connectors2024-08-08
• K150542 — Terumo Pump Tubing2015-05-01
• K142607 — AngioVac Circuit2014-12-11
• K092486 — VORTEX MEDICAL ANGIOVAC CARDIOPULMONARY BYPASS CIRCUIT2009-08-28
• K080592 — HLM TUBING SET WITH BIOLINE COATING2008-09-11

• K843955 — EXTRACORPOREAL MAXIMA HOLLOW FIBER OXYGENATOR1984-11-29
• K840262 — HANCOCK PERICARDIAL PATCH1984-05-30
• K840532 — HEMOPERFUSION SYSTEM TP-4001984-05-30
• K840057 — EXP* 500 PARALLEL PLATE DIALYZER1984-02-04
• K840146 — EXP* 700 PARALLEL PLATE DIALYZER1984-02-04

Death

9

Malfunction

754

Total

763

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-2736-2015 — MEDTRONIC PERFUSION TUBING PACKS (with potentially affected Hemoconcentrators). Model # 7U65R2, 8C72R4, 6N21R2, BB7M38R11, TL2Q68R17, HY8R66R3, HY2U43R9, 8C72R4, BB5J59R19, 6B65R3, TL7M46R7, TL2Q68R17, 7U65R2, M074704B, M230002A, BB7M38Rll, M450013B, BB8N86R4, HY2U43R9, 8C72R4, M650123A, HY8R55R ,TL7M46R7, M971406C, M450013B, 7U65R2, M394415A, M450013B. Enables the perfusionist to manage the patient's hematocrit and fluid status.Class II·Terminated·Medtronic Perfusion Systems·20150818
• Z-1000-2014 — Medtronic Intersept Custom Tubing Pack which contain Select 3D or Select CAP Arterial Cannulae. Model 3Y90R3, the following model is only approved in Europe C300901B. Sterilized using Ethylene Oxide. Non-pyrogenic. The design and components of this product are specified by the user. This product is indicated for use in the extracorporeal circuit during cardiopulmonary bypass procedures.Class II·Terminated·Medtronic Inc. Cardiac Rhythm Disease Management·20140130
• Z-2104-2013 — Medtronic Custom Perfusion System. Model Numbers: 1D80R8, 1E34R1, 1F75R1, 1G49R2, 1G75R1, 1P07R8, 1P91R4, 5B15R11, and 5P51R9. Sterilized by Ethylene Oxide, Do no Reuse. Product Usage: This product is indicated for use in the extracorporeal circuit during cardiopulmonary surgery.Class II·Terminated·Medtronic Inc. Cardiac Rhythm Disease Management·20130717
• Z-0618-2013 — Medtronic Intersept Custom Tubing Pack with or without coating ( Carmeda BioActive Surfact, Carmeda BioActive Surfact and Trillium Biosurface,or Balance Biosurface) with the following Model numbers: 0E27R16, 1A30R6, 2493R24, 2493R25, 5D56R5, 5Z93R4, 5Z93R5, 7E64R2, 7J53R2, 7M13R1, 7M14R1, 7N16R, 7P25R1, 7P93R1, 7Q11R1, BB7L63R2, BB7N26R, CB5174R11, CB175R13, CB5Q03R6, CB5Q03R7, CB6C53R6, CB7C15R2, CB7C59R2, CB7C60R2, CB7C74R2, CB7D91R5, CB7E35R2, CB7E38R1, CB7G21R4, CB7L48R1, CB7L72R1, CB7P82R1, HY6U96R2, HY6Y52R2, HY7E87R1, SS7J91R3, SSCB7L48R, SSTL7G78R1,TL5S33R7, TL6VTTR1, TL7B51R1, TL7G20R3, TL7G78R3, TL7R87R1. Sterilized Using Ethylene Oxide, Nonpyrogenic, Assembled in Mexico, Manufacturer Medtronic, Inc, Minneapolis, Mn 55432 Product is used by perfusionists as part of the extracorporeal circuit during cardiopulmonary bypass procedures, and is configured specifically as designated by each customer.Class II·Terminated·Medtronic Inc. Cardiac Rhythm Disease Management·20121119

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K800178.