Name: FDA 510(k) clearance K842799
Creator: U.S. Food and Drug Administration
Published: 1984-08-10

Clearance details

Applicant: American Edwards Laboratories
Product code: Code DQO
Device class: Class 2
Regulation: 21 CFR 870.1200
Advisory panel: Cardiovascular
Date received: 1984-07-17
Decision date: 1984-08-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Recent devices under product code DQO

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K261455 — Arterial Pressure Monitoring Set/Tray2026-06-26
K252702 — Bioptimal Pulmonary Artery Monitoring Catheter (TD2502NF, TD2502NGF, TD2502NDF, TD2502NCF, TD2502NCGF, TD2502NDGF, TD2502NDCF, TD2502NDCGF, TD2502NXCF, TD2502NDXF, TD2502NXCGF, TD2502NDXGF, TD2502NDXCF, TD2502NDXCGF, TD2502-110NF, TD2502-110NGF, TD2502-110NDF, TD2502-110NCF, TD2502-110NDGF, TD2502-110NDCF, TD2502-110NCGF, TD2502-110NDCGF, TD2502-110NXF, TD2502-110NXGF, TD2502-110NDXF, TD2502-110NXCF, TD2502-110NDXGF, TD2502-110NDXCF ,TD2502-110NXCGF, TD2502-110NDXCGF, TD2602NF, TD2602N2026-05-28
K254278 — Arterial Pressure Monitoring Set/Tray2026-03-25
K250751 — DualView Catheter2025-07-17
K242966 — Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging Catheter2025-01-31

More clearances from American Edwards Laboratories

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K873485 — EDSLAB (R) OCCLUSION BALLOON CATHETER1987-12-03
K872596 — TRANTEC DISPOSABLE PRESSURE TRANS.53-600/F/F301987-09-30
K872529 — THERMODILUTION CARDIAC OUTPUT COMPUTER, MOD. COM-21987-09-15
K870444 — HOMEPRO II VOLUMETRIC INFUSION PUMP1987-04-17
K864997 — MEDTRAC VP VOLUMETRIC INFUSION PUMP1987-02-27

Adverse events under product code DQO

product code DQO

Death: 35
Injury: 993
Malfunction: 1,772
Other: 5
Total: 2,805

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →