FDA product code DTS: Sucker, Cardiotomy Return, Cardiopulmonary Bypass
DTS is the FDA product code for sucker, cardiotomy return, cardiopulmonary bypass. It is a Class II device, regulated under 21 CFR 870.4420 and reviewed by the Cardiovascular panel. FDA has cleared 9 510(k) submissions under DTS, from 8 different applicants. The average 510(k) review took 91 days (median 64). FDA has posted 11 recalls for DTS devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Sucker, Cardiotomy Return, Cardiopulmonary Bypass |
| Device class | Class II |
| Regulation | 21 CFR 870.4420 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every DTS clearance
Top DTS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Gish Biomedical, Inc. | 2 | 1991-01-23 |
| Estech, Inc. | 1 | 2006-01-26 |
| California Medical Laboratories, Inc. | 1 | 1998-09-30 |
| International Biophysics Corp. | 1 | 1997-11-14 |
| Shiley, Inc. | 1 | 1990-03-28 |
3 more applicants have DTS clearances. See the full list in Caduvo.
Most recent DTS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K053021 | Estech, Inc. | ESTECH CLEARVIEW MV ATRIAL DEPRESSOR | 2006-01-26 | 92 |
| K982891 | California Medical Laboratories, Inc. | CALIFORNIA MEDICAL LABORATORIES INC. STANDARD AND SMALL RIGID TIP SUCTION WANDS | 1998-09-30 | 44 |
| K963756 | International Biophysics Corp. | IBC CARDIAC SUCTION WARD | 1997-11-14 | 423 |
| K905008 | Gish Biomedical, Inc. | FLEXIBLE INTRACARDIAC SUCTION DEVICE | 1991-01-23 | 78 |
| K900339 | Shiley, Inc. | HAND-HELD INTRACARDIAC SUCKERS W/ERGONOMIC HANDLES | 1990-03-28 | 64 |
Recalls for DTS devices
11 product recalls in 7 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2024-03-19.
| Year | Recalls |
|---|---|
| 2024 | 1 |
Frequently asked questions
What is FDA product code DTS?
DTS is the FDA product code for sucker, cardiotomy return, cardiopulmonary bypass. It is a Class II device, regulated under 21 CFR 870.4420 and reviewed by the Cardiovascular panel.
What device class is DTS?
Class II, regulation 21 CFR 870.4420. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code DTS?
Across 9 cleared submissions the average was 91 days from receipt to decision (median 64).
Which companies have the most DTS clearances?
Gish Biomedical, Inc. (2); Estech, Inc. (1); California Medical Laboratories, Inc. (1); International Biophysics Corp. (1); Shiley, Inc. (1).
Have DTS devices been recalled?
Yes: 11 product recalls across 7 recall events; the most recent began 2024-03-19.
Next steps
- Run an FDA pathway report with predicate devices for product code DTS
- Run a recall and safety report across every DTS manufacturer
- Watch product code DTS for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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