Servator H SALF solution-1000 ml PVC free bags, Servator H SALF solution-2000 ml PVC free bags— 510(k) K170150

Name: FDA 510(k) clearance K170150
Creator: U.S. Food and Drug Administration
Published: 2017-10-20

Substantially Equivalent

S.A.L.F. Spa

FDA 510(k) clearance K170150 for Servator H SALF solution-1000 ml PVC free bags, Servator H SALF solution-2000 ml PVC free bags, Substantially Equivalent on 2017-10-20. Applicant: S.A.L.F. Spa. Device class: 2.

Clearance details

Applicant: S.A.L.F. Spa
Product code: Code KDL
Device class: Class 2
Regulation: 21 CFR 876.5880
Advisory panel: Gastroenterology, Urology
Date received: 2017-01-17
Decision date: 2017-10-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cenate Sotto, IT

Download summary PDF View on FDA.gov ↗

Recent devices under product code KDL

view all

K241239 — OrganProtex HTK Solution2025-01-24
K221386 — PERF-GEN Pulsatile Perfusion Solution2022-06-14
K221387 — BEL-GEN Cold Storage Solution2022-06-14
K211842 — Servator M SALF Solution2021-12-20
K192408 — Custodiol HTK Solution2020-04-24

More clearances from S.A.L.F. Spa

view all

K230193 — Servator P Plus SALF Solution2023-09-21
K202652 — Servator P SALF Solution with THAM2021-08-19
K190063 — Servator C SALF Solution2019-08-14
K180481 — Servator B SALF Solution2018-06-29

Data sourced from openFDA. This site is unofficial and independent of the FDA.