Swan Ganz Catheter Placement Kit
FDA 510(k) K802288 · Stanco Medical, Inc.
510(k) numberK802288
Submission
- Device name
- Swan Ganz Catheter Placement Kit
- Applicant
- Stanco Medical, Inc.
Mchenry, IL, US - Received
- September 19, 1980
- Decision date
- November 20, 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 |
|---|---|---|
| K810643 | Universal Pacing Electrode KitLDF · Traditional | 04/08/1981SE |
| K810642 | Atrial-Ventricular Pacing Electrode KitLDF · Traditional | 04/08/1981SE |
| K802289 | Pericardiocentesis KitDOR · Traditional | 11/26/1980SE |
| K802287 | Right Atrial Line KitDQY · Traditional | 11/20/1980SE |
| K802259 | Transvenous Pacemaker Electrode KitLDF · Traditional | 10/23/1980SE |
| K802290 | Regional Intravenous Anesthesia KitCAZ · Traditional | 10/17/1980SE |
| K802328 | Disp. Tougy-Borst Type Adaptor W/PortDTZ · Traditional | 10/10/1980SE |
| K802327 | Sheath Dilator SetDRE · Traditional | 10/10/1980SE |
| K802326 | Pressure Monitoring LinesDRI · Traditional | 10/10/1980SE |
| K802260 | Vascular Catheter WireguidesDQX · Traditional | 10/10/1980SE |
Questions and answers
When was Swan Ganz Catheter Placement Kit cleared by the FDA?
Swan Ganz Catheter Placement Kit (K802288) received a 510(k) decision of Substantially Equivalent on November 20, 1980, 62 days after the submission was received.
What is the product code of K802288?
The FDA product code is DYG – Catheter, Flow Directed, a Class II (moderate risk) device regulated under 21 CFR 870.1240.