Umbilical Vessels Catheter
FDA 510(k) clearance K201697 · decided 2021-05-06
Clearance details
- K-number
- K201697
- Device name
- Umbilical Vessels Catheter
- Applicant
- Haolang Medical USA Corporation
- Decision
- Substantially Equivalent
- Date received
- 2020-06-22
- Decision date
- 2021-05-06
- Days to decision
- 318 days
- Clearance type
- Traditional
- Product code
- FOS
- Device class
- 2
- Regulation number
- 880.5200
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Bellevue, WA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.