CORE FM System, Patient Interface Module (OPIM), Hemodynamic Converter Box
FDA 510(k) K152582 · Volcano Corporation
510(k) numberK152582
Submission
- Device name
- CORE FM System, Patient Interface Module (OPIM), Hemodynamic Converter Box
- Applicant
- Volcano Corporation
San Diego, CA, US - Received
- September 10, 2015
- Decision date
- December 3, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DSK – Computer, Blood-Pressure
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1110
- Specialty
- Cardiovascular
Other 510(k)s with product code DSK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K231586 | Endophys Blood Pressure Monitor model BPM-30DSK · Traditional | Endophys Technologies, LLC | 11/03/2023SE |
| K160945 | Endophys Blood Pressure MonitorDSK · Traditional | Endophys Holdings, LLC | 09/26/2016SE |
| K141615 | Endophys Blood Pressure MonitorDSK · Traditional | Endophys, Inc. | 01/07/2015SE |
| K080670 | Modification to Sphygmocor Cardiovascular Management SystemDSK · Special | Atcor Medical | 04/23/2008SE |
| K070795 | Sphygmocor Cardiovascular Management SystemDSK · Traditional | Atcor Medical Pty, Ltd. | 08/31/2007SE |
| K033738 | Monitoring System, Model Argus PB-2200DSK · Traditional | Schiller AG | 08/24/2004SE |
| K021517 | Abp for WindowsDSK · Traditional | Rozinn Electronics, Inc. | 07/24/2002SE |
| K013943 | Radianalyzer, Model 12710, Radiview (Pc-Software Accessory), Model 12720DSK · Special | Radi Medical Systems AB | 12/18/2001SE |
| K011865 | Zoll M Series Ibp Operation; Zoll M Series Temperature OptionDSK · Traditional | Zoll Medical Corp | 07/31/2001SE |
| K003122 | Smartflow, Model Sfip 2000DSK · Traditional | Florence Medical , Ltd. | 05/14/2001SE |
More from Florence Medical , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K210235 | Verrata PLUS Pressure Guide WireDQX · Special | 04/15/2021SE |
| K203719 | IntraSight MobileIYO · Special | 01/19/2021SE |
| K202543 | OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm…DQX · Special | 09/28/2020SE |
| K192886 | OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm…DQX · Traditional | 03/26/2020SE |
| K190626 | SyncVision SystemOWB · Traditional | 04/12/2019SE |
| K190078 | IntraSightDSA · Special | 02/11/2019SE |
| K173860 | s5 Intravascular Ultrasound Imaging and Pressure Systems, s5i Intravascular Ultrasound…IYO · Traditional | 04/11/2018SE |
| K172455 | CORE M2 Vascular System, CORE M2 Software v4.2 Upgrade Kit, CORE M2 Software v4.2…IYO · Special | 10/25/2017SE |
| K172574 | SyncVision SystemOWB · Traditional | 10/05/2017SE |
| K170385 | CORE M2 Vascular SystemIYO · Special | 04/06/2017SE |
Questions and answers
When was CORE FM System, Patient Interface Module (OPIM), Hemodynamic Converter Box cleared by the FDA?
CORE FM System, Patient Interface Module (OPIM), Hemodynamic Converter Box (K152582) received a 510(k) decision of Substantially Equivalent on December 3, 2015, 84 days after the submission was received.
What is the product code of K152582?
The FDA product code is DSK – Computer, Blood-Pressure, a Class II (moderate risk) device regulated under 21 CFR 870.1110.