MODIFIED ARGYLE POLYURETHANE UMBILICAL VESSEL CATHETER 2.5FR, 3.5FR, 5 FR.— 510(k) K130725
Substantially EquivalentCovidien Lp, Formerly Registered AS Kendall
FDA 510(k) clearance K130725 for MODIFIED ARGYLE POLYURETHANE UMBILICAL VESSEL CATHETER 2.5FR, 3.5FR, 5 FR., Substantially Equivalent on 2013-04-17. Applicant: Covidien Lp, Formerly Registered AS Kendall. Device class: 2.
Clearance details
- Applicant
- Covidien Lp, Formerly Registered AS Kendall
- Product code
- Code FOS
- Device class
- Class 2
- Regulation
- 21 CFR 880.5200
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Mansfield, MA, US
Recent devices under product code FOS
view allMore clearances from Covidien Lp, Formerly Registered AS Kendall
view allAdverse events under product code FOS
product code FOS- Death
- 12
- Other
- 1
- Total
- 13
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 K130725
K-number listed on FDA's recall record- Z-1871-2025 — Catalog No. 8888160325; Umbilical Vessel Catheter 2.5 French single lumen
- Z-1872-2025 — Catalog No. 8888160333; Umbilical Vessel Catheter 3.5 French single lumen
- Z-1873-2025 — Catalog No. 8888160341; Umbilical Vessel Catheter 5 French single lumen
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K130725.
Data sourced from openFDA. This site is unofficial and independent of the FDA.