Sucker, Cardiotomy Return, Cardiopulmonary Bypass
FDA product code DTS · Class II (moderate risk) · 21 CFR 870.4420 · Cardiovascular
9510(k) clearances
0PMA approvals
11recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K053021 | Estech Clearview MV Atrial DepressorDTS · Traditional | Estech, Inc. | 01/26/2006SE |
| K982891 | California Medical Laboratories Inc. Standard and Small Rigid Tip Suction WandsDTS · Traditional | California Medical Laboratories, Inc. | 09/30/1998SE |
| K963756 | Ibc Cardiac Suction WardDTS · Traditional | International Biophysics Corp. | 11/14/1997SE |
| K905008 | Flexible Intracardiac Suction DeviceDTS · Traditional | Gish Biomedical, Inc. | 01/23/1991SE |
| K900339 | Hand-Held Intracardiac Suckers W/Ergonomic HandlesDTS · Traditional | Shiley, Inc. | 03/28/1990SE |
| K891906 | Robicsek Intracardiac Suction WandDTS · Traditional | Gish Biomedical, Inc. | 06/13/1989SE |
| K801641 | Ohio Disposable Clear Suction InstrumentDTS · Traditional | Ohio Medical Products | 07/28/1980SE |
| K801400 | Disposable Sucker SystemDTS · Traditional | Texas Medical Products, Inc. | 06/30/1980SE |
| K791846 | Dispossable Suction Tube, 6 FrenchDTS · Traditional | Dlp, Inc. | 10/02/1979SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1804-2024 Class II | Medtronic Suction Tubes: a) DLP Suction Tube 6-Fr. Shaft with Frazier Tip, Model Number:…Potential for unsealed sterile packing. | Medtronic Perfusion Systems | 03/19/2024Open, Classified |
| Z-2422-2015 Class II | IBC Suction Wand Catalog Number 1990S Product Usage: The IBC Suction Wand is a component…It was discovered that the heat seal placed onto sterile pouches may not meet strength acceptance criteria. | International Biophysics Corp. | 08/07/2015Terminated |
| Z-0650-2013 Class II | Rigid Tip Suction Wand Non sterile bulk devices (S112468N, S120196N, and S120197N) were…California Medical Laboratories, Inc. has identified an issue with the Rigid Tip Suction Wand. Due to… | California Medical Laboratories Inc | 11/02/2012Terminated |
| Z-0649-2013 Class II | Sterile Rigid Tip Suction Wand The Suction Wands are indicated for use to remove excess…California Medical Laboratories, Inc. has identified an issue with the Rigid Tip Suction Wand. Due to… | California Medical Laboratories Inc | 11/02/2012Terminated |
| Z-0273-2012 | IBC INTERNATIONAL BIOPHYSICS CORP. 2101-2 EAST ST. ELMO, SUITE 275, AUSTIN, TX 78744…Potential for the sterility to be compromised. | International Biophysics Corp | 10/05/2011Terminated |
| Z-0054-2012 | SARNS INTRACARDIAC SUCKER, BULK, NON-STERILETerumo Cardiovascular Systems (Terumo CVS) recently discovered three instances of metal fragments inside the… | Terumo Cardiovascular Systems Corporation | 09/13/2011Terminated |
| Z-0053-2012 | Sarns Rigid Intracardiac Sucker. The subject device is a single use, sterile device with…Terumo Cardiovascular Systems (Terumo CVS) recently discovered three instances of metal fragments inside the… | Terumo Cardiovascular Systems Corporation | 09/13/2011Terminated |
| Z-2046-2009 | Terumo Sarns cardiovascular disposable products, Weighted Flexible Sucker, sterile…A loose strand of stainless steel left on the device during manufacturing may result in an unretrieved metal… | Terumo Cardiovascular Systems Corporation | 02/05/2008Terminated |
| Z-1177-2008 | CalMed Malleable Pericardial Sump, Single Use Only. Do Not Reuse. REF SU-20802; CalMed…Fragment of material: The product may have a loose, stainless steel stringer flash located at the distal tip… | California Medical Laboratories Inc | 01/24/2008Terminated |
| Z-1176-2008 | CalMed Pericardial Sump, with 1/4"/0.635 cm Connector, Single Use Only. Do Not Reuse…Fragment of material: The product may have a loose, stainless steel stringer flash located at the distal tip… | California Medical Laboratories Inc | 01/24/2008Terminated |
| Z-1175-2008 | CalMed Pericardial Sump, with 1/8"/0.3175 cm Connector Single Use Only. Do Not Reuse.…Fragment of material: The product may have a loose, stainless steel stringer flash located at the distal tip… | California Medical Laboratories Inc | 01/24/2008Terminated |