Dispossable Suction Tube, 6 French
FDA 510(k) K791846 · Dlp, Inc.
510(k) numberK791846
Submission
- Device name
- Dispossable Suction Tube, 6 French
- Applicant
- Dlp, Inc.
Mchenry, IL, US - Received
- September 19, 1979
- Decision date
- October 2, 1979
- 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 |
| K801400 | Disposable Sucker SystemDTS · Traditional | Texas Medical Products, Inc. | 06/30/1980SE |
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| K953945 | Retrograde Coronary Sinus Perfusion Cannula with Elongated & Treaded Cuff & Introducer…DWF · Traditional | 03/26/1996SE |
| K950754 | Macro Suction Tube Model No 10061GCY · Traditional | 04/25/1995SE |
| K934215 | Contain-OrKKX · Traditional | 02/09/1994SE |
| K915268 | Catheter Two Stage Venous ReturnDWF · Traditional | 07/27/1992SE |
| K914608 | Breast Les Local Wire St. 48219/49220/48119/48120GAA · Traditional | 01/09/1992SE |
| K913077 | Lancaster Cooling Jacket, Cat. Code #13500/13501DTR · Traditional | 01/09/1992SE |
| K913098 | Apiration Biopsy Syringe Gun, Cat. Code #54501KNW · Traditional | 11/05/1991SE |
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Questions and answers
When was Dispossable Suction Tube, 6 French cleared by the FDA?
Dispossable Suction Tube, 6 French (K791846) received a 510(k) decision of Substantially Equivalent on October 2, 1979, 13 days after the submission was received.
What is the product code of K791846?
The FDA product code is DTS – Sucker, Cardiotomy Return, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4420.