PiCCO Catheter
FDA 510(k) K171620 · Pulsion Medical Systems SE
510(k) numberK171620
Submission
- Device name
- PiCCO Catheter
- Applicant
- Pulsion Medical Systems SE
Feldkirchen, DE - Received
- June 2, 2017
- Decision date
- February 21, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KRB – Probe, Thermodilution
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1915
- Specialty
- Cardiovascular
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| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K100739 | Volumeview System, Models VLV520FT6R, VLV520FT8R, VLV520FT6R5KRB · Traditional | Edwards Lifesciences, LLC | 12/07/2010SE |
| K072364 | Pulsion Pulsiocath Thermodilution Catheters & AccessoriesKRB · Special | Pulsion Medical Systems AG | 09/19/2007SE |
| K020587 | Pulsion Pulsiocath Picco Monitoring Kit, Injectate Sensor Temperature Housing PV 4046KRB · Traditional | Pulsion Medical Systems AG | 05/23/2002SE |
| K991886 | Pulsion Pulsiocath, Pulsion Pcco Monitoring Kit, Pulsion In-Line Injectate SensorKRB · Traditional | Pulsion Medical Systems, Inc. | 05/11/2000SE |
| K936182 | Critikit Plus in Line Room/Ice Temperature Injectate KitKRB · Traditional | Ohmeda Medical | 03/25/1994SE |
| K915627 | PaceviewKRB · Traditional | Micromedical Industries, Ltd. | 03/27/1992SE |
| K912172 | Safewedge(Tm) Relief Valve DeviceKRB · Traditional | Sunscope Intl., Inc. | 09/27/1991SE |
| K902627 | Interflo Medical Model Oxi/Co Fila. Thermo. Cath.KRB · Traditional | Biometric Research Institute, Inc. | 02/25/1991SE |
| K900710 | Interflo Medical Model F-1 Thermodilution CatheterKRB · Traditional | Intec Medical, Inc. | 10/19/1990SE |
| K900317 | Pacemate Flow Directed Thermal Dilution CatheterKRB · Traditional | Elecath | 06/22/1990SE |
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| 510(k) | Device | Decision |
|---|---|---|
| K192169 | PulsioFlex Monitoring System with ProAQT SensorDXG · Traditional | 04/30/2020SE |
| K172259 | PulsioFlex Monitoring SystemDXG · Traditional | 01/18/2018SE |
| K122121 | Pulsioflex Monitoring System with Picco ModuleDXG · Special | 08/02/2012SE |
| K112448 | PulsioflexDXG · Special | 09/22/2011SE |
| K091786 | Pulsion PICCO2 (8500), Cevox Optical Module (PC3015), Cevox Disposable Probes (PV2022-30…DXG · Traditional | 06/18/2010SE |
| K072735 | Pulsion PICCO-2, Model 8500DXG · Special | 10/18/2007SE |
| K072364 | Pulsion Pulsiocath Thermodilution Catheters & AccessoriesKRB · Special | 09/19/2007SE |
| K060898 | Pulsion Picco Plus, Model 8100DXG · Traditional | 07/25/2006SE |
| K020587 | Pulsion Pulsiocath Picco Monitoring Kit, Injectate Sensor Temperature Housing PV 4046KRB · Traditional | 05/23/2002SE |
| K001762 | Pulsion Continuous Pulse Contour Cardiac Output (Picco) SystemDXG · Traditional | 06/13/2000SE |
Questions and answers
When was PiCCO Catheter cleared by the FDA?
PiCCO Catheter (K171620) received a 510(k) decision of Substantially Equivalent on February 21, 2018, 264 days after the submission was received.
What is the product code of K171620?
The FDA product code is KRB – Probe, Thermodilution, a Class II (moderate risk) device regulated under 21 CFR 870.1915.