DTS
9 FDA 510(k) clearances · Product code
64 daysmedian time to decision
423 days90th percentile
9clearances measured
FDA profile
- Official device name
- Sucker, Cardiotomy Return, Cardiopulmonary Bypass
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4420
- Medical specialty
- Cardiovascular
- Adverse events (MAUDE)
- 2005: 4 · 2006: 5 · 2012: 8 · 2014: 107 · 2024: 20 · 2025: 17
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| ESTECH CLEARVIEW MV ATRIAL DEPRESSOR (K053021) | Estech, Inc. | 2006-01-26 |
| CALIFORNIA MEDICAL LABORATORIES INC. STANDARD AND SMALL RIGID TIP SUCTION WANDS (K982891) | California Medical Laboratories, Inc. | 1998-09-30 |
| IBC CARDIAC SUCTION WARD (K963756) | International Biophysics Corp. | 1997-11-14 |
| FLEXIBLE INTRACARDIAC SUCTION DEVICE (K905008) | Gish Biomedical, Inc. | 1991-01-23 |
| HAND-HELD INTRACARDIAC SUCKERS W/ERGONOMIC HANDLES (K900339) | Shiley, Inc. | 1990-03-28 |
| ROBICSEK INTRACARDIAC SUCTION WAND (K891906) | Gish Biomedical, Inc. | 1989-06-13 |
| OHIO DISPOSABLE CLEAR SUCTION INSTRUMENT (K801641) | Ohio Medical Products | 1980-07-28 |
| DISPOSABLE SUCKER SYSTEM (K801400) | Texas Medical Products, Inc. | 1980-06-30 |
| DISPOSSABLE SUCTION TUBE, 6 FRENCH (K791846) | Dlp, Inc. | 1979-10-02 |
Track DTS automatically
Every clearance here is in the API, with alerts when new ones post.