Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging Catheter— 510(k) K242966
Substantially EquivalentGentuity, LLC
FDA 510(k) clearance K242966 for Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging Catheter, Substantially Equivalent on 2025-01-31. Applicant: Gentuity, LLC. Device class: 2.
Clearance details
- Applicant
- Gentuity, LLC
- Product code
- Code DQO
- Device class
- Class 2
- Regulation
- 21 CFR 870.1200
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sudbury, MA, US
Recent devices under product code DQO
view all- K261455 — Arterial Pressure Monitoring Set/Tray
- 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, TD2602N
- K254278 — Arterial Pressure Monitoring Set/Tray
- K250751 — DualView Catheter
- K242420 — pNOVUS 21 Microcatheter
More clearances from Gentuity, LLC
view allAdverse events under product code DQO
product code DQO- Death
- 35
- Injury
- 993
- Malfunction
- 1,772
- Other
- 5
- Total
- 2,805
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 K242966
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K242966.
Data sourced from openFDA. This site is unofficial and independent of the FDA.