Name: FDA 510(k) clearance K121954
Creator: U.S. Food and Drug Administration
Published: 2012-07-17

Clearance details

Applicant: Navilyst Medical, Inc.
Product code: Code DQO
Device class: Class 2
Regulation: 21 CFR 870.1200
Advisory panel: Cardiovascular
Date received: 2012-07-03
Decision date: 2012-07-17
Decision: Substantially Equivalent
Clearance type: Special
Location: Marlborough, MA, US

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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 Navilyst Medical, Inc.

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K163452 — PICC Maximal Barrier Nursing Kit2017-02-03
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K153228 — NMI Port, NMI Port II2015-12-04
K152069 — Exodus Array Multipurpose Drainage Catheter, Exodus Nuance Nephrostomy Drainage Catheter, Exodus Believe Biliary Drainage Catheter2015-09-24

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 →