# K083301: X-Coated Terumo and Sarns Dual Stage Venous Return Catheters, Sarns Malleable Venous and Dual Stage Return Catheters

- Pathway: 510(k) (Special)
- Applicant: Terumo Cardiovascular Systems Corp.
- Decided: Dec 18, 2008 after 38 days
- Product code: DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4210
- Recalls of this device: 37 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K770429 (1977). 3 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K920902: Modification of Sarns Two Stage Venous Cannula, 3M Health Care, Sarns (1993) Summary page 2.
- K905224: Cardiopulmonary Bypass Vascular Catheter, 3M Health Care, Sarns (1991) Summary page 2.
- K770429: Cannulae, Aortic, Arch, High Flow, 3M Health Care, Sarns (1977) Summary page 2.
- (no number) Terumo® Dual-Stage Venous Return Cannula: named in the summary without a submission number
- (no number) SarnsTM Malleable Dual Stage Venous Return Catheters: named in the summary without a submission number
- (no number) SarnsTM Soft-FlowTM Extended Aortic Cannula: named in the summary without a submission number

## Most influential descendants
- K132811: Sarns Soft-Flow Extended Aortic Cannula (2014), 0 descendants of its own
- K132451: Sarns Soft-Flow Aortic Cannula (2014), 0 descendants of its own
- K133151: Sarns High Flow Aortic Arch Cannula (2014), 0 descendants of its own

## Recalls of this device
- May 23, 2014 · Class II · Z-2097-2014: During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications
- May 23, 2014 · Class II · Z-2096-2014: During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications
- Jan 7, 2013 · Class II · Z-0667-2013: Flexible Arterial Cannula and High-Flow Aortic Arch Cannula connectors were identified to contain flash on the exterior of the cannula connector that exceeded established specifications. Because the f
- Jan 7, 2013 · Class II · Z-0668-2013: Flexible Arterial Cannula and High-Flow Aortic Arch Cannula connectors were identified to contain flash on the exterior of the cannula connector that exceeded established specifications. Because the f
- Jan 7, 2013 · Class II · Z-0670-2013: Flexible Arterial Cannula and High-Flow Aortic Arch Cannula connectors were identified to contain flash on the exterior of the cannula connector that exceeded established specifications. Because the f
- Jan 7, 2013 · Class II · Z-0671-2013: Flexible Arterial Cannula and High-Flow Aortic Arch Cannula connectors were identified to contain flash on the exterior of the cannula connector that exceeded established specifications. Because the f
- Jan 7, 2013 · Class II · Z-0666-2013: Flexible Arterial Cannula and High-Flow Aortic Arch Cannula connectors were identified to contain flash on the exterior of the cannula connector that exceeded established specifications. Because the f
- Jan 7, 2013 · Class II · Z-0669-2013: Flexible Arterial Cannula and High-Flow Aortic Arch Cannula connectors were identified to contain flash on the exterior of the cannula connector that exceeded established specifications. Because the f
- May 9, 2012 · Class II · Z-1834-2012: During production of one lot of the Sarns High-Flow Aortic Arch Cannula, Terumo Cardiovascular Systems (Terumo CVS) found a foreign substance on the outer surface of some cannulae connectors. Terumo C
- Feb 23, 2012 · Not classified · Z-1294-2012: During in-house inspection, Terumo Cardiovascular Systems discovered one Soft-Flow Aortic Cannula with a hole in the tip, just above the suture ball.
- Feb 23, 2012 · Not classified · Z-1297-2012: During in-house inspection, Terumo Cardiovascular Systems discovered one Soft-Flow Aortic Cannula with a hole in the tip, just above the suture ball.
- Feb 23, 2012 · Not classified · Z-1313-2012: During in-house inspection, Terumo Cardiovascular Systems discovered one Soft-Flow Aortic Cannula with a hole in the tip, just above the suture ball.
- Feb 23, 2012 · Not classified · Z-1302-2012: During in-house inspection, Terumo Cardiovascular Systems discovered one Soft-Flow Aortic Cannula with a hole in the tip, just above the suture ball.
- Feb 23, 2012 · Not classified · Z-1310-2012: During in-house inspection, Terumo Cardiovascular Systems discovered one Soft-Flow Aortic Cannula with a hole in the tip, just above the suture ball.
- Feb 23, 2012 · Not classified · Z-1299-2012: During in-house inspection, Terumo Cardiovascular Systems discovered one Soft-Flow Aortic Cannula with a hole in the tip, just above the suture ball.
- Feb 23, 2012 · Not classified · Z-1309-2012: During in-house inspection, Terumo Cardiovascular Systems discovered one Soft-Flow Aortic Cannula with a hole in the tip, just above the suture ball.
- Feb 23, 2012 · Not classified · Z-1300-2012: During in-house inspection, Terumo Cardiovascular Systems discovered one Soft-Flow Aortic Cannula with a hole in the tip, just above the suture ball.
- Feb 23, 2012 · Not classified · Z-1305-2012: During in-house inspection, Terumo Cardiovascular Systems discovered one Soft-Flow Aortic Cannula with a hole in the tip, just above the suture ball.
- Feb 23, 2012 · Not classified · Z-1301-2012: During in-house inspection, Terumo Cardiovascular Systems discovered one Soft-Flow Aortic Cannula with a hole in the tip, just above the suture ball.
- Feb 23, 2012 · Not classified · Z-1307-2012: During in-house inspection, Terumo Cardiovascular Systems discovered one Soft-Flow Aortic Cannula with a hole in the tip, just above the suture ball.
- Feb 23, 2012 · Not classified · Z-1293-2012: During in-house inspection, Terumo Cardiovascular Systems discovered one Soft-Flow Aortic Cannula with a hole in the tip, just above the suture ball.
- Feb 23, 2012 · Not classified · Z-1298-2012: During in-house inspection, Terumo Cardiovascular Systems discovered one Soft-Flow Aortic Cannula with a hole in the tip, just above the suture ball.
- Feb 23, 2012 · Not classified · Z-1292-2012: During in-house inspection, Terumo Cardiovascular Systems discovered one Soft-Flow Aortic Cannula with a hole in the tip, just above the suture ball.
- Feb 23, 2012 · Not classified · Z-1306-2012: During in-house inspection, Terumo Cardiovascular Systems discovered one Soft-Flow Aortic Cannula with a hole in the tip, just above the suture ball.
- Feb 23, 2012 · Not classified · Z-1296-2012: During in-house inspection, Terumo Cardiovascular Systems discovered one Soft-Flow Aortic Cannula with a hole in the tip, just above the suture ball.
- Feb 23, 2012 · Not classified · Z-1287-2012: During in-house inspection, Terumo Cardiovascular Systems discovered one Soft-Flow Aortic Cannula with a hole in the tip, just above the suture ball.
- Feb 23, 2012 · Not classified · Z-1291-2012: During in-house inspection, Terumo Cardiovascular Systems discovered one Soft-Flow Aortic Cannula with a hole in the tip, just above the suture ball.
- Feb 23, 2012 · Not classified · Z-1288-2012: During in-house inspection, Terumo Cardiovascular Systems discovered one Soft-Flow Aortic Cannula with a hole in the tip, just above the suture ball.
- Feb 23, 2012 · Not classified · Z-1304-2012: During in-house inspection, Terumo Cardiovascular Systems discovered one Soft-Flow Aortic Cannula with a hole in the tip, just above the suture ball.
- Feb 23, 2012 · Not classified · Z-1290-2012: During in-house inspection, Terumo Cardiovascular Systems discovered one Soft-Flow Aortic Cannula with a hole in the tip, just above the suture ball.
- Feb 23, 2012 · Not classified · Z-1311-2012: During in-house inspection, Terumo Cardiovascular Systems discovered one Soft-Flow Aortic Cannula with a hole in the tip, just above the suture ball.
- Feb 23, 2012 · Not classified · Z-1312-2012: During in-house inspection, Terumo Cardiovascular Systems discovered one Soft-Flow Aortic Cannula with a hole in the tip, just above the suture ball.
- Feb 23, 2012 · Not classified · Z-1295-2012: During in-house inspection, Terumo Cardiovascular Systems discovered one Soft-Flow Aortic Cannula with a hole in the tip, just above the suture ball.
- Feb 23, 2012 · Not classified · Z-1303-2012: During in-house inspection, Terumo Cardiovascular Systems discovered one Soft-Flow Aortic Cannula with a hole in the tip, just above the suture ball.
- Feb 23, 2012 · Not classified · Z-1314-2012: During in-house inspection, Terumo Cardiovascular Systems discovered one Soft-Flow Aortic Cannula with a hole in the tip, just above the suture ball.
- Feb 23, 2012 · Not classified · Z-1308-2012: During in-house inspection, Terumo Cardiovascular Systems discovered one Soft-Flow Aortic Cannula with a hole in the tip, just above the suture ball.
- Feb 23, 2012 · Not classified · Z-1289-2012: During in-house inspection, Terumo Cardiovascular Systems discovered one Soft-Flow Aortic Cannula with a hole in the tip, just above the suture ball.

## Indications for use
The X-coating is intended to reduce the adhesion of platelets to the blood contacting surfaces of the device during cardiopulmonary bypass procedures. The X-coated Terumo® Dual-Stage Venous Return Cannula is indicated for use for adult single tube blood drainage from the right atrium and inferior vena cava (IVC) and delivery of the blood to the extracorporeal circuit during cardiopulmonary bypass. The X-coated SarnsTM Dual-Stage Venous Return Catheters are indicated for single tube venous drainage from the right atrium and vena cava during cardiopulmonary bypass surgery. The SarnsTM Malleable Venous Return Catheters are indicated for venous drainage during cardiopulmonary bypass surgery: the 24, 28, 30, 32, 34, 36 and 40 Fr. are for dual cannulation of the superior and inferior vena cava; the 40 Fr. is-for single cannulation of the right atrium. The X-coated SarnsTM Malleable Dual-Stage Venous Return Catheters are indicated for single-tube venous drainage from the right atrium and vena cava during cardiopulmonary bypass surgery. The X-coated SarnsTM High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. The X-coated SarnsTM Soft-FlowTM Extended Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.

Source page: https://510kreport.com/device/K083301
Methodology: https://510kreport.com/methodology