Sucker, Cardiotomy Return, Cardiopulmonary Bypass
The Cardiotomy Return Sucker for Cardiopulmonary Bypass is a cardiovascular surgical device used to aspirate blood from the surgical field and return it to the extracorporeal circuit for filtration and recirculation during open-heart procedures, reducing blood loss. It is classified as an FDA Class 2 device, indicating moderate risk, and requires 510(k) premarket notification before marketing. The product code is DTS and it is regulated under 21 CFR 870.4420 within the Cardiovascular medical specialty.
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Basic Information
- Product Code
- DTS
- Device Class
- FDA class 2
- Regulation Number
- 870.4420
- Medical Specialty
- Cardiovascular
- Review Panel
- CV
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 9 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K053021 | ESTECH CLEARVIEW MV ATRIAL DEPRESSOR | Jan 26, 2006 | Substantially Equivalent | Estech, Inc. |
| K982891 | CALIFORNIA MEDICAL LABORATORIES INC. STANDARD AND SMALL RIGID TIP SUCTION WANDS | Sep 30, 1998 | Substantially Equivalent | California Medical Laboratories, Inc. |
| K963756 | IBC CARDIAC SUCTION WARD | Nov 14, 1997 | Substantially Equivalent | International Biophysics Corp. |
| K905008 | FLEXIBLE INTRACARDIAC SUCTION DEVICE | Jan 23, 1991 | Substantially Equivalent | Gish Biomedical, Inc. |
| K900339 | HAND-HELD INTRACARDIAC SUCKERS W/ERGONOMIC HANDLES | Mar 28, 1990 | Substantially Equivalent | Shiley, Inc. |
| K891906 | ROBICSEK INTRACARDIAC SUCTION WAND | Jun 13, 1989 | Substantially Equivalent | Gish Biomedical, Inc. |
| K801641 | OHIO DISPOSABLE CLEAR SUCTION INSTRUMENT | Jul 28, 1980 | Substantially Equivalent | Ohio Medical Products |
| K801400 | DISPOSABLE SUCKER SYSTEM | Jun 30, 1980 | Substantially Equivalent | Texas Medical Products, Inc. |
| K791846 | DISPOSSABLE SUCTION TUBE, 6 FRENCH | Oct 02, 1979 | Substantially Equivalent | Dlp, Inc. |
FEI Numbers
This FDA classification entry is associated with 26 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 26 registration numbers. Click on an entry to view related FDA registrations.