Polyurethane Thermal Dilution Cathet
FDA 510(k) K841876 · Waters Instruments, Inc.
510(k) numberK841876
Submission
- Device name
- Polyurethane Thermal Dilution Cathet
- Applicant
- Waters Instruments, Inc.
Mchenry, IL, US - Received
- May 7, 1984
- Decision date
- July 13, 1984
- 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
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|---|---|---|---|
| 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 |
|---|---|---|
| K053169 | RM3 Renal Preservation SystemKDK · Special | 01/17/2006SE |
| K042224 | RM3 Renal Preservation SystemKDN · Special | 10/22/2004SE |
| K971571 | RM3 Renal Preservation System--Control UnitKDN · Traditional | 07/29/1997SE |
| K921519 | OXICOM-2100DQA · Traditional | 10/23/1992SE |
| K911207 | OxicomplusDQA · Traditional | 08/26/1991SE |
| K863210 | VELCOM-100DPW · Traditional | 11/26/1986SE |
| K862161 | OSC-80 OximeterDQA · Traditional | 08/18/1986SE |
| K852909 | MVP - 6000BZC · Traditional | 11/14/1985SE |
| K834408 | TX-2 Thermal Dilution Cardiac OutputDXG · Traditional | 08/23/1984SE |
| K813585 | Waters Ileostomy ValveKNT · Traditional | 04/09/1982SE |
Questions and answers
When was Polyurethane Thermal Dilution Cathet cleared by the FDA?
Polyurethane Thermal Dilution Cathet (K841876) received a 510(k) decision of Substantially Equivalent on July 13, 1984, 67 days after the submission was received.
What is the product code of K841876?
The FDA product code is DYG – Catheter, Flow Directed, a Class II (moderate risk) device regulated under 21 CFR 870.1240.