510(k) clearances

Aletta® Autonomous Robotic Phlebotomy Device (ARPD™) (Gen1 US)

Vitestro · General Hospital

DEN250046UnknownDirectSIW
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Third party flag
N
City
Utrecht
Advisory committee description
General Hospital
Address 1
Europalaan Unit 1.N.2
Product code
SIW
Zip code
3526 KS
Applicant
Vitestro
Decision date
2026-08-19
Decision code
DENG
Country code
NL
Device name
Aletta® Autonomous Robotic Phlebotomy Device (ARPD™) (Gen1 US)
Advisory committee
HO
Contact
Luuk Giesen
K number
DEN250046
Date received
2025-09-26
Review advisory committee
HO
Postal code
3526 KS
Decision description
Unknown
Clearance type
Direct
Harmonized identifiers (openFDA)
Device name
Robotic Peripheral Venous Blood Collection System
Medical specialty description
General Hospital
Regulation number
880.6975
Device class
2
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.