Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced Monitoring Platform— 510(k) K231248
Substantially EquivalentEdwards Lifesciencess, LLC
FDA 510(k) clearance K231248 for Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced Monitoring Platform, Substantially Equivalent on 2023-09-21. Applicant: Edwards Lifesciencess, LLC. Device class: 2.
Clearance details
- Applicant
- Edwards Lifesciencess, LLC
- Product code
- Code DYG
- Device class
- Class 2
- Regulation
- 21 CFR 870.1240
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irvine, CA, US
Recent devices under product code DYG
view allAdverse events under product code DYG
product code DYG- Death
- 18
- Malfunction
- 1,051
- Other
- 1
- Total
- 1,070
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K231248
K-number listed on FDA's recall record- Z-2202-2026 — Swan-Ganz Catheter, Models: 131F7/131F7P, 131F7J, 141F7, 151F7, 834F75, 096F6/096F6P, C144F7, 782F75M, 132F5, C146F7, 831F75/831F75P, TS105F5, 774F75, 777F8, AIQSGF8;
- Z-2203-2026 — Swan-Ganz Jr Catheter, Models: SGPT54, SGPT64P, SGPT755P
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K231248.
Data sourced from openFDA. This site is unofficial and independent of the FDA.