Catheter, Cardiovascular
FDA 510(k) K771823 · Usci, Div. C.R. Bard, Inc.
510(k) numberK771823
Submission
- Device name
- Catheter, Cardiovascular
- Applicant
- Usci, Div. C.R. Bard, Inc.
Mchenry, IL, US - Received
- September 23, 1977
- Decision date
- December 20, 1977
- 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 |
|---|---|---|
| K940092 | Usci Input Introducer SetDYB · Traditional | 08/10/1995SE |
| K884209 | Usci Dorros Infusion/Probing CatheterDQY · Traditional | 12/21/1988SE |
| K772021 | TRC Stainless Steel Safety Spring GuidesDQX · Traditional | 11/02/1977SE |
| K771982 | 888 Arterial/Venous Catheter IntroducerDYB · Traditional | 11/02/1977SE |
| K770835 | Patch FabricDXZ · Traditional | 10/05/1977SE |
| K770561 | Catheter,Percutaneous Introduc. & SheathDYB · Traditional | 04/26/1977SE |
| K770236 | Sauvage Filamentous ProsthesesDSY · Traditional | 02/25/1977SE |
| K770235 | Debakey Vasculour-D ProsthesesDSY · Traditional | 02/24/1977SE |
| K760843 | Paley Transparent ManifoldDTL · Traditional | 11/12/1976SE |
| K760403 | Temporary Atrial Electrode KitDRE · Traditional | 08/23/1976SE |
Questions and answers
When was Catheter, Cardiovascular cleared by the FDA?
Catheter, Cardiovascular (K771823) received a 510(k) decision of Substantially Equivalent on December 20, 1977, 88 days after the submission was received.
What is the product code of K771823?
The FDA product code is DYG – Catheter, Flow Directed, a Class II (moderate risk) device regulated under 21 CFR 870.1240.