Probe & Catheter
FDA 510(k) K771663 · Edwards Laboratories
510(k) numberK771663
Submission
- Device name
- Probe & Catheter
- Applicant
- Edwards Laboratories
Walker, MI, US - Received
- August 30, 1977
- Decision date
- September 20, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| 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 |
More from Intec Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K801552 | Mod. 9542 Flow-Thru Inject. Temp. SensorKRB · Traditional | 07/28/1980SE |
| K800655 | Model 100 SpectraviewDQC · Traditional | 04/16/1980SE |
| K792441 | Carpentier-Edwards Flex. AnnuloplastyKRH · Traditional | 03/17/1980PT |
| K792034 | Integral Disposable Holder CarpentierDTJ · Traditional | 12/07/1979SE |
| K790047 | Cardiac Output Computer, Mdel 9520ADXG · Traditional | 02/26/1979SE |
| K790022 | Disposable Holder for BioprosthesisDTJ · Traditional | 01/15/1979SE |
| K781535 | Ac Adapter:Models 9525,9526,9527DXG · Traditional | 09/15/1978SE |
| K771046 | Vena Cava Umbrella Filter, Model 7321DTK · Traditional | 06/22/1977SE |
| K760151 | Applicator,Angiography (7310MOBIN-UDDIN)DTK · Traditional | 08/26/1976SE |
| K760192 | Computer, Thermodilution Cardiac (9520)DXG · Traditional | 07/19/1976SE |
Questions and answers
When was Probe & Catheter cleared by the FDA?
Probe & Catheter (K771663) received a 510(k) decision of Substantially Equivalent on September 20, 1977, 21 days after the submission was received.
What is the product code of K771663?
The FDA product code is KRB – Probe, Thermodilution, a Class II (moderate risk) device regulated under 21 CFR 870.1915.