DTS · Sucker, Cardiotomy Return, Cardiopulmonary Bypass
Cardiovascular · 21 CFR 870.4420 · Class 2
Overview
| Product Code | DTS |
|---|---|
| Device Name | Sucker, Cardiotomy Return, Cardiopulmonary Bypass |
| Regulation | 21 CFR 870.4420 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
Identification
A cardiopulmonary bypass cardiotomy return sucker is a device that consists of tubing, a connector, and a probe or tip that is used to remove blood from the chest or heart during cardiopulmonary bypass surgery.
Classification Rationale
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
Recent Cleared Devices (9 of 9)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K053021 | ESTECH CLEARVIEW MV ATRIAL DEPRESSOR | Estech, Inc. | Jan 26, 2006 | SESE |
| K982891 | CALIFORNIA MEDICAL LABORATORIES INC. STANDARD AND SMALL RIGID TIP SUCTION WANDS | California Medical Laboratories, Inc. | Sep 30, 1998 | SESE |
| K963756 | IBC CARDIAC SUCTION WARD | International Biophysics Corp. | Nov 14, 1997 | SESE |
| K905008 | FLEXIBLE INTRACARDIAC SUCTION DEVICE | Gish Biomedical, Inc. | Jan 23, 1991 | SESE |
| K900339 | HAND-HELD INTRACARDIAC SUCKERS W/ERGONOMIC HANDLES | Shiley, Inc. | Mar 28, 1990 | SESE |
| K891906 | ROBICSEK INTRACARDIAC SUCTION WAND | Gish Biomedical, Inc. | Jun 13, 1989 | SESE |
| K801641 | OHIO DISPOSABLE CLEAR SUCTION INSTRUMENT | Ohio Medical Products | Jul 28, 1980 | SESE |
| K801400 | DISPOSABLE SUCKER SYSTEM | Texas Medical Products, Inc. | Jun 30, 1980 | SESE |
| K791846 | DISPOSSABLE SUCTION TUBE, 6 FRENCH | Dlp, Inc. | Oct 2, 1979 | SESE |
Top Applicants
- Gish Biomedical, Inc. — 2 clearances
- Texas Medical Products, Inc. — 1 clearance
- Shiley, Inc. — 1 clearance
- Ohio Medical Products — 1 clearance
- International Biophysics Corp. — 1 clearance
