SARTORIUS MINI-SART FH 16555— 510(k) K851817

Name: FDA 510(k) clearance K851817
Creator: U.S. Food and Drug Administration
Published: 1985-08-19

Substantially Equivalent

Sartorius Filters, Inc.

FDA 510(k) clearance K851817 for SARTORIUS MINI-SART FH 16555, Substantially Equivalent on 1985-08-19. Applicant: Sartorius Filters, Inc.. Device class: 2.

Clearance details

Applicant: Sartorius Filters, Inc.
Product code: Code FPB
Device class: Class 2
Regulation: 21 CFR 880.5440
Advisory panel: General Hospital
Date received: 1985-04-26
Decision date: 1985-08-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hayward, CA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Sartorius Filters, Inc.

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K851816 — SARTORIUS MINISART FH 165341985-08-19
K851818 — SARTORIUS MINI SART FH 165921985-08-19
K850435 — SARTORIUS AQUASART SM 40035 - DIALYSATE SYS1985-06-04
K844504 — SARTORIUS MINISART SM 16596HY1985-01-18
K830487 — HEMO-PROCESSING SYSTEM1983-04-28

Adverse events under product code FPB

product code FPB

Other: 1
Total: 1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.