Ohio Disposable Clear Suction Instrument
FDA 510(k) K801641 · Ohio Medical Products
510(k) numberK801641
Submission
- Device name
- Ohio Disposable Clear Suction Instrument
- Applicant
- Ohio Medical Products
Mchenry, IL, US - Received
- July 17, 1980
- Decision date
- July 28, 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 |
| K801400 | Disposable Sucker SystemDTS · Traditional | Texas Medical Products, Inc. | 06/30/1980SE |
| K791846 | Dispossable Suction Tube, 6 FrenchDTS · Traditional | Dlp, Inc. | 10/02/1979SE |
More from Dlp, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K841733 | Ohio Waste Gas Scavenging ReservoirCBN · Traditional | 07/11/1984SE |
| K842003 | Ohio Waste Gas Scavenging InterfaceCBN · Traditional | 05/23/1984SE |
| K840356 | Ohio Unitrol II Anesthesia Gas MachineBSZ · Traditional | 04/20/1984SE |
| K841274 | Bag-To-Ventilator Selector ValveBSZ · Traditional | 04/13/1984SE |
| K840967 | Ohio Heat Reflecting PatchFMI · Traditional | 03/23/1984SE |
| K840858 | Ohio 3300 Infant Warmer SystemFMT · Traditional | 03/23/1984SE |
| K840857 | Ohio 3000 Infant Warmer SystemFMT · Traditional | 03/23/1984SE |
| K840453 | Medishield PVM RespirometerBZK · Traditional | 03/02/1984SE |
| K840452 | Premium Dabm Dispos. Anes. Breath MaskBSJ · Traditional | 02/17/1984SE |
| K833335 | Modulus II Anesthesia Gas MachineBSZ · Traditional | 11/14/1983SE |
Questions and answers
When was Ohio Disposable Clear Suction Instrument cleared by the FDA?
Ohio Disposable Clear Suction Instrument (K801641) received a 510(k) decision of Substantially Equivalent on July 28, 1980, 11 days after the submission was received.
What is the product code of K801641?
The FDA product code is DTS – Sucker, Cardiotomy Return, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4420.