Umbilical Vessels Catheter— 510(k) K201697
Substantially EquivalentHaolang Medical USA Corporation
FDA 510(k) clearance K201697 for Umbilical Vessels Catheter, Substantially Equivalent on 2021-05-06. Applicant: Haolang Medical USA Corporation. Device class: 2.
Clearance details
- Applicant
- Haolang Medical USA Corporation
- 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
- Traditional
- Location
- Bellevue, WA, US
Recent devices under product code FOS
view all- K130725 — MODIFIED ARGYLE POLYURETHANE UMBILICAL VESSEL CATHETER 2.5FR, 3.5FR, 5 FR.
- K120304 — FOOTPRINT MEDICAL POLYURETHANE UMBILICAL CATHETER
- K091213 — FOOTPRINT MEDICAL UMBILICAL CATHETER, DUAL LUMEN
- K091214 — FOOTPRINT MEDICAL SILICONE UMBILICAL CATHETER
- K081515 — NEOMED DUAL LUMEN UMBILICAL CATHETER, MODELS S2UVC4.0, S2UVC5.0
More clearances from Haolang Medical USA Corporation
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.