Catheter, Pacing/Monitoring
FDA 510(k) K772059 · Electro-Catheter Corp.
510(k) numberK772059
Submission
- Device name
- Catheter, Pacing/Monitoring
- Applicant
- Electro-Catheter Corp.
Mchenry, IL, US - Received
- October 31, 1977
- Decision date
- November 15, 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 |
|---|---|---|
| K934785 | MultipaceLDF · Traditional | 07/27/1995SE |
| K943257 | Tip Deflector (Genesis)DRF · Traditional | 04/19/1995SE |
| K933451 | Open Tip Multi-Electrode Catheter, ModificationDRF · Traditional | 04/19/1995SE |
| K933450 | Closed Tip Multi-Electrode Catheter, ModificationDRF · Traditional | 04/19/1995SE |
| K934787 | Silicore Semi-FloaterLDF · Traditional | 02/24/1995SE |
| K874154 | Elecath(R) Transesophageal Pacing CatheterKNT · Traditional | 04/29/1988SE |
| K854511 | Elecath Percutaneous Left Atrial Cannulation SetDQX · Traditional | 02/10/1986SE |
| K854975 | Elecath Pulsatile Perfusion PumpKFM · Traditional | 01/15/1986SE |
| K850065 | Elecath Torkfloat Pacing ProbeDTB · Traditional | 04/10/1985SE |
| K850324 | Elecath Open Tip Bipolar Pacing CatheterLDF · Traditional | 03/27/1985SE |
Questions and answers
When was Catheter, Pacing/Monitoring cleared by the FDA?
Catheter, Pacing/Monitoring (K772059) received a 510(k) decision of Substantially Equivalent on November 15, 1977, 15 days after the submission was received.
What is the product code of K772059?
The FDA product code is DYG – Catheter, Flow Directed, a Class II (moderate risk) device regulated under 21 CFR 870.1240.