Disposable Sucker System
FDA 510(k) K801400 · Texas Medical Products, Inc.
510(k) numberK801400
Submission
- Device name
- Disposable Sucker System
- Applicant
- Texas Medical Products, Inc.
Walker, MI, US - Received
- June 13, 1980
- Decision date
- June 30, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DTS – Sucker, Cardiotomy Return, Cardiopulmonary Bypass
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4420
- Specialty
- Cardiovascular
Other 510(k)s with product code DTS
| 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 |
| K791846 | Dispossable Suction Tube, 6 FrenchDTS · Traditional | Dlp, Inc. | 10/02/1979SE |
More from Dlp, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K893417 | Surgifresh Sub-Micron Mask No. 901008-000FXX · Traditional | 06/22/1989SE |
| K870932 | Surgifresh Surgical Smoke Removal · Traditional | 03/31/1987SE |
| K851575 | Dr. Bruno Lnage Mini Photometer · Traditional | 10/18/1985SE |
| K830634 | Cardiotomy FilterJOD · Traditional | 06/30/1983SE |
| K813587 | Disposable Thoracic CatheterGBS · Traditional | 01/12/1982SE |
| K810532 | Disposable StopcockDTZ · Traditional | 04/23/1981SE |
| K810515 | Disposable 2-STAGE CannulaDWF · Traditional | 04/23/1981SE |
| K810395 | Pre-Bypass FilterKRJ · Traditional | 03/05/1981SE |
| K802545 | Cardioplegic SetsDTR · Traditional | 01/16/1981SE |
| K802544 | Disposable Quick Release Perfusion AdapDTL · Traditional | 01/16/1981SE |
Questions and answers
When was Disposable Sucker System cleared by the FDA?
Disposable Sucker System (K801400) received a 510(k) decision of Substantially Equivalent on June 30, 1980, 17 days after the submission was received.
What is the product code of K801400?
The FDA product code is DTS – Sucker, Cardiotomy Return, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4420.