Continous Cardiac Output Pulmonary Artery Catheter, Model Trucath, Continous Cardiac Output Monitor, Model Truccom
FDA 510(k) K993245 · Alba Critical Care, Ltd.
510(k) numberK993245
Submission
- Device name
- Continous Cardiac Output Pulmonary Artery Catheter, Model Trucath, Continous Cardiac Output Monitor, Model Truccom
- Applicant
- Alba Critical Care, Ltd.
Bellshill, Lanarkshire, GB - Received
- September 28, 1999
- Decision date
- October 28, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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 |
Questions and answers
When was Continous Cardiac Output Pulmonary Artery Catheter, Model Trucath, Continous Cardiac Output Monitor, Model Truccom cleared by the FDA?
Continous Cardiac Output Pulmonary Artery Catheter, Model Trucath, Continous Cardiac Output Monitor, Model Truccom (K993245) received a 510(k) decision of Substantially Equivalent on October 28, 1999, 30 days after the submission was received.
What is the product code of K993245?
The FDA product code is DYG – Catheter, Flow Directed, a Class II (moderate risk) device regulated under 21 CFR 870.1240.