HOSPIRA CATH LAB CONVENIENCE KITS— 510(k) K052865
Substantially EquivalentIcu Medical, Inc.
FDA 510(k) clearance K052865 for HOSPIRA CATH LAB CONVENIENCE KITS, Substantially Equivalent on 2005-12-22. Applicant: Icu Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Icu Medical, Inc.
- 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
- Special
- Location
- Lake Forest, IL, 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
- K242966 — Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging Catheter
More clearances from Icu Medical, Inc.
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 K052865
K-number listed on FDA's recall record- Z-2128-2012 — High Pressure Stopcock (3-Way, Luer Lock, Off). Product Usage: For IV.
- Z-2129-2012 — Cardiac Catheterization Waste Management System w/1000mL Waste Bag, 2 Fluid Admin Sets Product Usage: For waste managment.
- Z-2131-2012 — Flush Kit w 3 Way Off Stopcock Product Usage: Flush Kit
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K052865.
Data sourced from openFDA. This site is unofficial and independent of the FDA.