4F Sterile Balloon-Less, Catheter 913-28
FDA 510(k) K791026 · Waters Assoc., Inc.
510(k) numberK791026
Submission
- Device name
- 4F Sterile Balloon-Less, Catheter 913-28
- Applicant
- Waters Assoc., Inc.
Mchenry, IL, US - Received
- June 4, 1979
- Decision date
- June 22, 1979
- 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
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|---|---|---|---|
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| 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 |
|---|---|---|
| K811975 | Model 480 Variable Wavelength Ultra ViolJJQ · Traditional | 07/27/1981SE |
| K802481 | 7FRENCH Flow Directed Triple Lumen CathDYG · Traditional | 10/31/1980SE |
| K801852 | MRM-2 Oxygen Consumption MonitorBZL · Traditional | 08/20/1980SE |
| K801431 | Pan-Am Myelogram TrayFMI · Traditional | 08/12/1980SE |
| K791661 | System Controller 720 SeriesKIE · Traditional | 09/24/1979SE |
| K790145 | Solvent Delivery SystemKIE · Traditional | 02/15/1979SE |
| K782175 | Cartridge Holder, RCM 100KIE · Traditional | 02/15/1979SE |
| K781805 | Cardiac Computers, CO-10 & CO-10RDXG · Traditional | 01/29/1979SE |
| K781915 | Data ModuleKIE · Traditional | 01/10/1979SE |
| K781692 | Calibrator, DynamicDXM · Traditional | 11/29/1978SE |
Questions and answers
When was 4F Sterile Balloon-Less, Catheter 913-28 cleared by the FDA?
4F Sterile Balloon-Less, Catheter 913-28 (K791026) received a 510(k) decision of Substantially Equivalent on June 22, 1979, 18 days after the submission was received.
What is the product code of K791026?
The FDA product code is KRB – Probe, Thermodilution, a Class II (moderate risk) device regulated under 21 CFR 870.1915.