Orth-Evac(Tm) Suction Hand Bulb Model No. 01-150
FDA 510(k) K910211 · Deknatel, Inc.
510(k) numberK910211
Submission
- Device name
- Orth-Evac(Tm) Suction Hand Bulb Model No. 01-150
- Applicant
- Deknatel, Inc.
San Jose-Heredia, CR - Received
- January 15, 1991
- Decision date
- April 3, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CAC – Apparatus, Autotransfusion
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5830
- Specialty
- Anesthesiology
- Life-sustaining
- Yes
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| K241236 | XTRA Collection sets; XTRA Sequestration set XCAC · Special | Sorin Group Italia S.R.L. | 08/16/2024SE |
| K240426 | Aventus Clot Management SystemCAC · Traditional | Inquis Medical | 05/14/2024SE |
| K240584 | XTRA Autotransfusion System (with XTRA Bowl sets)CAC · Special | Sorin Group Italia S.R.L. | 04/29/2024SE |
| K231782 | FlowSaver Blood Return System (80-101)CAC · Special | Inari Medical, Inc. | 07/14/2023SE |
| K221483 | FlowSaver Blood Return SystemCAC · Traditional | Inari Medical, Inc. | 02/17/2023SE |
| K221722 | Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US)CAC · Traditional | Haemonetics Corporation | 11/15/2022SE |
| K201305 | Auto transfusion (ATS) Chest Drains: Ocean Water Seal Chest Drain, Oasis Dry Suction…CAC · Traditional | Atrium Medical Corporation | 09/03/2021SE |
| K210862 | Hemafuse SystemCAC · Traditional | Sisu Global Health | 07/29/2021SE |
| K210176 | FlowSaver Blood FilterCAC · Traditional | Inari Medical | 07/22/2021SE |
| K210089 | CATSmart, Automated Blood Processing Autotransfusion SystemCAC · Special | Fresenius Kabi AG | 02/11/2021SE |
More from Fresenius Kabi AG
| 510(k) | Device | Decision |
|---|---|---|
| K963850 | Pleur-Evac Sahara Plus Model S-1150 Continuous Reinfusion Autotransfusion SystemCAC · Traditional | 04/22/1997SE |
| K962683 | Snowden-Pencer Computerized High Flow InsufflatorHIF · Traditional | 01/10/1997SE |
| K964070 | Deknatel DSP Pleur-Evac Autotransfusion Blood Recovery BagCAC · Traditional | 12/31/1996SE |
| K963098 | Pleur-Evac Shara Plus Model S-2150/CONTINUOUS Reinfusion Autotransfusion SYSTEM(S-100)CAC · Traditional | 11/08/1996SE |
| K962856 | Pleur-Evac Sahara Adult/Pediatric Chest Drainage System Model S-1100, S-1200, 2-2100…KDQ · Traditional | 08/28/1996SE |
| K925243 | Deknatel(Tm) Pleur-Evac(R) Thoracic CatheterGBX · Traditional | 07/27/1994SE |
| K930740 | Surgical Suture, Nonabsorable Stainless SteelGAQ · Traditional | 07/26/1994SE |
| K930739 | Sutures Polyprop., Polyetheline, Nylon & SilkGAP · Traditional | 07/26/1994SE |
| K930738 | Surgical Sutures, PGL, Gut, Deklene, Opthamend EtcGAL · Traditional | 07/26/1994SE |
| K926338 | Pleur-Evac Cardiotomy Reservoir # CR-9400 & 9400FCAC · Traditional | 07/26/1994SE |
Questions and answers
When was Orth-Evac(Tm) Suction Hand Bulb Model No. 01-150 cleared by the FDA?
Orth-Evac(Tm) Suction Hand Bulb Model No. 01-150 (K910211) received a 510(k) decision of Substantially Equivalent on April 3, 1991, 78 days after the submission was received.
What is the product code of K910211?
The FDA product code is CAC – Apparatus, Autotransfusion, a Class II (moderate risk) device regulated under 21 CFR 868.5830.