ClearanceBrief
Panels › Cardiovascular › Product code DTS · Class 2

Sucker, Cardiotomy Return, Cardiopulmonary Bypass

Regulation 870.4420

0510(k)s in 12 months (9 all time)
0recalls in 12 months (11 all time)
8recalls that name a 510(k)
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Top companies in DTS

DateFirm and productCodeLinked 510(k)
May 10, 2024Medtronic Perfusion Systems
Medtronic Suction Tubes: a) DLP Suction Tube 6-Fr. Shaft with Frazier Tip, Model Number: 10050, b) DLP Suction Tube 6-Fr. Shaft with 10-Fr. Soft Tip, Model Number: 10052, c) DLP Suction Tube 6-Fr
Open, Classified
DTSNone listed
Aug 19, 2015International Biophysics Corp.
IBC Suction Wand Catalog Number 1990S Product Usage: The IBC Suction Wand is a component of Blood Recovery System for use in open heart procedures, autologous blood recovery and blood suction. It is
Terminated
DTSK963756
Jan 7, 2013California Medical Laboratories Inc
Rigid Tip Suction Wand Non sterile bulk devices (S112468N, S120196N, and S120197N) were sold to Terumo UK to be included in a kit under Terumo as manufacturer's name. The Suction Wands are indicated
Terminated
DTSK982891
Jan 7, 2013California Medical Laboratories Inc
Sterile Rigid Tip Suction Wand The Suction Wands are indicated for use to remove excess fluid from the surgical field.
Terminated
DTSK982891
Nov 23, 2011International Biophysics Corp
IBC INTERNATIONAL BIOPHYSICS CORP. 2101-2 EAST ST. ELMO, SUITE 275, AUSTIN, TX 78744 SUCTION HANDLE (STERILE) PART NUMBER: 1990S LOT NUMBER 041811-2065 EXPIRATION DATE: 18/APR/2015 For use in open h
Terminated
DTSK963756
Oct 17, 2011Terumo Cardiovascular Systems Corporation
SARNS INTRACARDIAC SUCKER, BULK, NON-STERILE
Terminated
DTSNone listed
Oct 17, 2011Terumo Cardiovascular Systems Corporation
Sarns Rigid Intracardiac Sucker. The subject device is a single use, sterile device with a 7.0 mm (21 FR) tip and 1/4 connector
Terminated
DTSNone listed
Aug 4, 2009Terumo Cardiovascular Systems Corporation
Terumo Sarns cardiovascular disposable products, Weighted Flexible Sucker, sterile, Terumo Cardiovascular Systems Corp., Ann Arbor, MI.; Catalog No. 804113.
Terminated
DTSK982891
Jun 11, 2008California Medical Laboratories Inc
CalMed Malleable Pericardial Sump, Single Use Only. Do Not Reuse. REF SU-20802; CalMed Laboratories, Costa Mesa, CA 92626
Terminated
DTSK982891
Jun 11, 2008California Medical Laboratories Inc
CalMed Pericardial Sump, with 1/4"/0.635 cm Connector, Single Use Only. Do Not Reuse; REF SU-20602; CalMed Laboratories, Costa Mesa, CA 92626
Terminated
DTSK982891
Jun 11, 2008California Medical Laboratories Inc
CalMed Pericardial Sump, with 1/8"/0.3175 cm Connector Single Use Only. Do Not Reuse. REF SU-20601; CalMed Laboratories, Costa Mesa, CA 92626
Terminated
DTSK982891

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