# K033264: Malleable Single Stage Venous Cannula with Carmeda Bioactive Surface, Model CB681XX Series

- Pathway: 510(k) (Special)
- Applicant: Medtronic Perfusion Systems
- Decided: Oct 31, 2003 after 22 days
- Product code: DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4210
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K845045 (1985). 2 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022272: Malleable Single Stage Venous Cannula, Models 68112-68140 (15 Total Codes), Medtronic Cardiac Surgical Products (2003)

## Cited in the summary but kept off the family tree
- K891868: Patient Examination Glove (Latex), Bber Sound Rubber Industrial Co., Ltd. (1989). Our reading of the summary gave K891868, FDA’s number for Patient Examination Glove (Latex) (Bber Sound Rubber Industrial Co., Ltd.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Extracorporeal Circuit with Bio-Active Surface”. Kept off the family tree. Summary page 1.

## Most influential descendants
- K111972: Affinity CP Centrifugal Pump, Resting Heart Sys.,Myotherm Cardioplegia Deliv.,Affinity Hollow Fiber Oxygenator,Aaf (2011), 5 descendants of its own
- K120988: DLP Single Stage Venous Cannula, DLP Right Angle Single Stage Venous Cannula, DLP Single Stage Venous Cannula with Right (2012), 4 descendants of its own
- K140165: MC2 Two-Stage Venous Cannula, Oval MC2 Two-Stage Venous Cannula, Thin Wall Two-Stage Venous Cannula, MC2X Three-Stage VE (2014), 2 descendants of its own
- K251258: MC2™ Two-Stage Venous Cannula; MC2X™ Three-Stage Venous Cannula (2025), 1 descendant of its own
- K262052: Tri Stage Venous Cannulae (2026), 0 descendants of its own

## Recalls of this device
- May 9, 2008 · Not classified · Z-1924-2008: Medtronic is recalling selected Carmeda-coated cardiopulmonary bypass (CPB) products (e.g., oxygenators, reservoirs, pumps, cannulae and tubing packs) that were manufactured with contaminated heparin.

## Indications for use
These cannulae are intended for collection of venous blood from the right side of the heart via the superior and inferior vena cava during cardiopulmonary bypass surgery up to six hours or less.

Source page: https://510kreport.com/device/K033264
Methodology: https://510kreport.com/methodology