# K973760: Affinity Hollow Fiber Oxygenator with Trillium Biopassive Surface

- Pathway: 510(k) (Traditional)
- Applicant: Avecor Cardiovascular, Inc.
- Decided: Feb 18, 1998 after 139 days
- Product code: DTZ (Oxygenator, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4350
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
35 later devices descend from it; 11 cite it directly.
2 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K011864: Trillium Myotherm XP Cardioplegia Delivery System, Models 41, 41-B (2001), 8 descendants of its own
- K060509: Palindrome Emerald 14.5 FR Chronic Hemodialysis Catheter with Heparin Coating (2006), 7 descendants of its own
- K033468: Affinity 20U Arterial Filter with Trillium Biosurface (2003), 7 descendants of its own
- K012743: Trillium Tri-Optic Measurement Cell, Model TMC 25T, TMC38 T, TMC 50T (2001), 7 descendants of its own
- K062671: 14.5 FR Chronic Hemodialysis Catheter with Heparin Coating and Silver Impregnated Sleeve (Palindrome Sapphire) (2006), 6 descendants of its own

## Recalls of this device
- Oct 1, 2007 · Not classified · Z-0476-2008: Unnaproved Component Resin: Affinity NT Integrated CVR Membrane Oxygenators and EL 240 Autotransfusion Blood Collection Reservoirs contain components made from an unapproved resin
- Mar 25, 2004 · Not classified · Z-0815-04: An incorrect date of manufacture and incorrect use-by date were printed on the labels of the pouches used for the product.

## Indications for use
The Affinity™ Hollow Fiber Membrane Oxygenator Systems are intended to be used in an extracorporeal perfusion circuit to oxygenate and remove carbon dioxide from the blood and to cool or warm the blood during routine cardiopulmonary bypass procedures up to 6 hours in duration.

Source page: https://510kreport.com/device/K973760
Methodology: https://510kreport.com/methodology