BP Transducer Holders TH-2,3 & 4
FDA 510(k) K832384 · American Bentley
510(k) numberK832384
Submission
- Device name
- BP Transducer Holders TH-2,3 & 4
- Applicant
- American Bentley
Mchenry, IL, US - Received
- July 19, 1983
- Decision date
- November 14, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DXO – Transducer, Pressure, Catheter Tip
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2870
- Specialty
- Cardiovascular
Other 510(k)s with product code DXO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251367 | OptoMonitor 3DXO · Traditional | Opsens, Inc. | 01/16/2026SE |
| K241418 | OptoMonitor 3DXO · Traditional | Opsens, Inc. | 02/12/2025SE |
| K233904 | ACIST RXi System (016616); ACIST Navvus II Catheter (016675_DXO · Traditional | Acist Medical Systems, Inc. | 07/17/2024SE |
| K222216 | TruWave Disposable Pressure TransducerDXO · Traditional | Edwards Lifesciences, LLC | 12/22/2022SE |
| K202943 | OptoMonitor 3DXO · Traditional | Opsens, Inc. | 11/24/2020SE |
| K193620 | OptoMonitor 3DXO · Traditional | Opsens, Inc. | 06/18/2020SE |
| K193279 | Comet II Pressure GuidewireDXO · Special | Boston Scientific Corporation | 12/23/2019SE |
| K192340 | OptoMonitorDXO · Traditional | Opsens, Inc. | 12/12/2019SE |
| K190852 | Zurich Pressure Guidewire System Model 100DXO · Traditional | Zurich Medical, Inc. | 08/14/2019SE |
| K183413 | TruWave Disposable Pressure TransducerDXO · Traditional | Edwards Lifeciences, LLC | 05/01/2019SE |
More from Edwards Lifeciences, LLC
| 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 BP Transducer Holders TH-2,3 & 4 cleared by the FDA?
BP Transducer Holders TH-2,3 & 4 (K832384) received a 510(k) decision of Substantially Equivalent on November 14, 1983, 118 days after the submission was received.
What is the product code of K832384?
The FDA product code is DXO – Transducer, Pressure, Catheter Tip, a Class II (moderate risk) device regulated under 21 CFR 870.2870.