FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Swan-Ganz Pacing Probe and Catheters; Swan-Ganz Bipolar Pacing Catheter (D97120F5); Swan-Ganz Bipolar Pacing Catheter (D97130F5); Swan-Ganz Pacing Thermodilution TD Catheter (D200F7); Chandler Transluminal V-Pacing Probe (D98100)
K Number: K233983
·
Decision Jun 27, 2024
Classifications
1
FEI Numbers
47
Registration Numbers
47
Same Product Code
98
Applicant Total
21
Review Days
192
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- Swan-Ganz Pacing Probe and Catheters; Swan-Ganz Bipolar Pacing Catheter (D97120F5); Swan-Ganz Bipolar Pacing Catheter (D97130F5); Swan-Ganz Pacing Thermodilution TD Catheter (D200F7); Chandler Transluminal V-Pacing Probe (D98100)
- K Number
- K233983
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1240
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Edwards Lifesciences
- Date Received
- December 18, 2023
- Decision Date
- June 27, 2024
- Product Code
- DYG
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DYG | Catheter, Flow Directed | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DYG), ordered by most recent decision date.
HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta- monitor pressure cable (HEMAPSC200);Acumen AFM cable- HemoSphere Alta monitor (HEMAFM100)
FDA 510(k)
FDA Class 2
·Cardiovascular
Swan-Ganz catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced Monitoring Platform
FDA 510(k)
FDA Class 2
·Cardiovascular
Swang-Ganz IQ pulmonary artery catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
Swan-Ganz Catheters
FDA 510(k)
FDA Class 2
·Cardiovascular
Swan Ganz Catheters
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by Edwards Lifesciences
| K Number | Device Name | ||
|---|---|---|---|
| K260105 | Fogarty Spring Clips, Handleless Clamps, and Clamp Inserts | Jun 5, 2026 | Substantially Equivalent |
| K254279 | Edwards eSheath+ introducer set | Apr 17, 2026 | Substantially Equivalent |
| K252533 | HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1) | Dec 18, 2025 | Substantially Equivalent |
| K253034 | HemoSphere Stream Module | Oct 21, 2025 | Substantially Equivalent |
| K252364 | Edwards eSheath Optima introducer set | Aug 29, 2025 | Substantially Equivalent |
| K243781 | HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere ClearSight Module (HEMCSM10); Smart Pressure Controller (PC1Q); Acumen IQ Plus Finger Cuff (AIQCA2); HemoSphere Pressure Cable (HEMPSC100); HemoSphere Vita Monitor (HEMVITA1); HemoSphere Vita Technology Module (HEMVTOM1); HemoSphere VitaWave module (HEMVWM1); VitaWave Plus finger cuff (VWCA2) | Jul 23, 2025 | Substantially Equivalent |
| K244046 | Edwards eSheath Optima introducer set | Mar 27, 2025 | Substantially Equivalent |
| K242451 | HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta- monitor pressure cable (HEMAPSC200);Acumen AFM cable- HemoSphere Alta monitor (HEMAFM100) | Dec 9, 2024 | Substantially Equivalent |
| K240596 | Cerebral Autoregulation Index (CAI) Algorithm | Oct 16, 2024 | Substantially Equivalent |
| K241330 | Fogarty Fortis Arterial Embolectomy Catheter | Jul 2, 2024 | Substantially Equivalent |