Pleural Drainage Sys #PDS-100-4
FDA 510(k) K831849 · American Bentley
510(k) numberK831849
Submission
- Device name
- Pleural Drainage Sys #PDS-100-4
- Applicant
- American Bentley
Walker, MI, US - Received
- June 8, 1983
- Decision date
- December 29, 1983
- 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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| 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 |
|---|---|---|
| K872896 | Umbilical Artery Oxygen Probe Model UAP-100CCE · Traditional | 02/12/1988SE |
| K873923 | Integrated Membrane Oxygenator W/Cardiotomy FilterDTZ · Traditional | 11/06/1987SE |
| K872167 | Cardiotomy/Mediastinal Auto. Reservoir CATR-3500DTP · Traditional | 09/01/1987SE |
| K870804 | Cardioplegia Heat Exchanger Model No. HE-100DTR · Traditional | 09/01/1987SE |
| K872133 | Oxygenator Model No. Bentley 5 PlusDTZ · Traditional | 08/24/1987SE |
| K870911 | Indwelling Blood Carbondioxide Partial Pres. AnalyCCC · Traditional | 05/29/1987SE |
| K870269 | Electrosurgical Meniscus Cutter (Emc) Mod. AMC-100GEI · Traditional | 03/09/1987SE |
| K863249 | Oxygenator Model No. BENTLEY-10 PlusDTZ · Traditional | 10/20/1986SE |
| K861641 | Heparin-Coated Extracorporeal CircuitsDTZ · Traditional | 09/29/1986SE |
| K862549 | Arterial Blood Filter Holder Model No. Af-HeKRI · Traditional | 07/15/1986SE |
Questions and answers
When was Pleural Drainage Sys #PDS-100-4 cleared by the FDA?
Pleural Drainage Sys #PDS-100-4 (K831849) received a 510(k) decision of Substantially Equivalent on December 29, 1983, 204 days after the submission was received.
What is the product code of K831849?
The FDA product code is CAC – Apparatus, Autotransfusion, a Class II (moderate risk) device regulated under 21 CFR 868.5830.