# K800178: Extracorp.'S Intersept Cus. Tubing PK.

- Pathway: 510(k) (Traditional)
- Applicant: Extracorporeal Medical Specialities, Inc.
- Decided: Feb 21, 1980 after 24 days
- Product code: DWE (Tubing, Pump, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4390
- Recalls of this device: 10 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
28 later devices descend from it; 3 cite it directly.
3 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K012538: Tubing and Connectors with Trillium Biopassive Surface (2001), 14 descendants of its own
- K053025: Jostra HLM Tubing Set (2005), 12 descendants of its own
- K080592: HLM Tubing Set with Bioline Coating (2008), 8 descendants of its own
- K113845: Tubing, Conmnectors, and Accessories Wit Balance Biosurface (2012), 7 descendants of its own
- K122811: Connector Components with Balance Biosurface (2012), 5 descendants of its own

## Recalls of this device
- Aug 18, 2015 · Class II · Z-2736-2015: Hemocor High Performance Hemoconcentrators demonstrate low ultrafiltration performance that is below product specification. These potentially affected units have been distributed as stand-alone device
- Jan 30, 2014 · Class II · Z-1000-2014: Medtronic is recalling all models of its Select 3D and Select CAP Arterial Cannula product families due to reports of the cannula body splitting near the suture collar.
- Jul 17, 2013 · Class II · Z-2104-2013: Medtronic was notified that Edwards Lifesciences has initiated a product recall for the Rigid Suction Wand, model S099B. The Wands are included within certain Perfusion Tubing Packs that are manufactu
- Nov 19, 2012 · Class II · Z-0618-2013: Medtronic is initiating an Urgent Medical Device Customer Notification. We have confirmed that certain Medtronic Intersept Tubing Packs contain packaging trays that are susceptible to damage that can 
- Dec 14, 2011 · Not classified · Z-0814-2012: Instructions for Use for the DLP Single Stage Venous Cannulae are in the process of being updated. The current precaution statement referencing ventricular assist procedures will be identified as a co
- Feb 25, 2009 · Not classified · Z-1424-2009: Sterility may be compromised. Non-vented caps that connect to the 3-way stopcock attached to the transfer spike could prevent Ethylene Oxide from contacting the inside surfaces of the stopcock during 
- Aug 1, 2007 · Not classified · Z-1227-2007: Medtronic Custom Tubing Packs might have open header bag seals.
- Jan 2, 2007 · Not classified · Z-0583-2007: One lot of Custom Perfusion Sets, Catalog 2T10R1 was incorrectly assembled. The one way vacuum relief valve on the 102 inch line is attached backwards, thus preventing flow.
- Sep 13, 2006 · Not classified · Z-0340-2007: An out of specification condition exists with the tapered tubing found in some Custom Tubing Packs. The wall thickness is undersized and does not meet specifications.
- Mar 25, 2005 · Not classified · Z-0808-05: Some warehouse inventory of Custom Pack product bags were found with ruptured seals. The seals were partially opened in the center of the bag's Tyvek edge. Since this bag is used to enclose and seal t

Source page: https://510kreport.com/device/K800178
Methodology: https://510kreport.com/methodology