7FRENCH Flow Directed Triple Lumen Cath
FDA 510(k) K802481 · Waters Assoc., Inc.
510(k) numberK802481
Submission
- Device name
- 7FRENCH Flow Directed Triple Lumen Cath
- Applicant
- Waters Assoc., Inc.
Mchenry, IL, US - Received
- October 7, 1980
- Decision date
- October 31, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DYG – Catheter, Flow Directed
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1240
- Specialty
- Cardiovascular
Other 510(k)s with product code DYG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K242451 | HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta-…DYG · Traditional | Edwards Lifesciences | 12/09/2024SE |
| K233983 | Swan-Ganz Pacing Probe and Catheters; Swan-Ganz Bipolar Pacing Catheter (D97120F5)…DYG · Traditional | Edwards Lifesciences | 06/27/2024SE |
| K233824 | Swan-Ganz catheterDYG · Traditional | Edwards Lifesciences, LLC | 06/06/2024SE |
| K231248 | Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced…DYG · Traditional | Edwards Lifesciencess, LLC | 09/21/2023SE |
| K222117 | Swang-Ganz IQ pulmonary artery catheterDYG · Traditional | Edwards Lifesiences, LLC | 12/09/2022SE |
| K193466 | Swan-Ganz CathetersDYG · Traditional | Edwards Lifesciences, LLC | 02/16/2020SE |
| K160084 | Swan Ganz CathetersDYG · Traditional | Edwards Lifesciences, LLC | 05/03/2016SE |
| K094048 | Percupro Messenger Balloon CatheterDYG · Traditional | Cardiosolutions, Inc. | 07/14/2011SE |
| K081052 | Occlusion Balloon Catheter, Model VenosDYG · Traditional | Oscor, Inc. | 06/18/2008SE |
| K010253 | Angio Flow Thermodilution Catheter, Model AF-CATH-01; Angioflow Meter, Models HQ100 and…DYG · Traditional | Transonic Systems, Inc. | 03/19/2002SE |
More from Transonic Systems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K811975 | Model 480 Variable Wavelength Ultra ViolJJQ · Traditional | 07/27/1981SE |
| 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 |
| K791026 | 4F Sterile Balloon-Less, Catheter 913-28KRB · Traditional | 06/22/1979SE |
| 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 7FRENCH Flow Directed Triple Lumen Cath cleared by the FDA?
7FRENCH Flow Directed Triple Lumen Cath (K802481) received a 510(k) decision of Substantially Equivalent on October 31, 1980, 24 days after the submission was received.
What is the product code of K802481?
The FDA product code is DYG – Catheter, Flow Directed, a Class II (moderate risk) device regulated under 21 CFR 870.1240.