Pulsion Pulsiocath Picco Monitoring Kit, Injectate Sensor Temperature Housing PV 4046
FDA 510(k) K020587 · Pulsion Medical Systems AG
510(k) numberK020587
Submission
- Device name
- Pulsion Pulsiocath Picco Monitoring Kit, Injectate Sensor Temperature Housing PV 4046
- Applicant
- Pulsion Medical Systems AG
Concord, MA, US - Received
- February 22, 2002
- Decision date
- May 23, 2002
- 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
Other 510(k)s with product code KRB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K171620 | PiCCO CatheterKRB · Traditional | Pulsion Medical Systems SE | 02/21/2018SE |
| 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 |
| 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 |
More from Elecath
| 510(k) | Device | Decision |
|---|---|---|
| K192169 | PulsioFlex Monitoring System with ProAQT SensorDXG · Traditional | 04/30/2020SE |
| K171620 | PiCCO CatheterKRB · Traditional | 02/21/2018SE |
| 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 |
| K001762 | Pulsion Continuous Pulse Contour Cardiac Output (Picco) SystemDXG · Traditional | 06/13/2000SE |
Questions and answers
When was Pulsion Pulsiocath Picco Monitoring Kit, Injectate Sensor Temperature Housing PV 4046 cleared by the FDA?
Pulsion Pulsiocath Picco Monitoring Kit, Injectate Sensor Temperature Housing PV 4046 (K020587) received a 510(k) decision of Substantially Equivalent on May 23, 2002, 90 days after the submission was received.
What is the product code of K020587?
The FDA product code is KRB – Probe, Thermodilution, a Class II (moderate risk) device regulated under 21 CFR 870.1915.