HAEMONETICS CELL SAVER MINI SAVER AUTO. BLOOD SYS.— 510(k) K872895

Name: FDA 510(k) clearance K872895
Creator: U.S. Food and Drug Administration
Published: 1988-01-11

Substantially Equivalent

Haemonetics Corp.

FDA 510(k) clearance K872895 for HAEMONETICS CELL SAVER MINI SAVER AUTO. BLOOD SYS., Substantially Equivalent on 1988-01-11. Applicant: Haemonetics Corp.. Device class: 1.

Clearance details

Applicant: Haemonetics Corp.
Product code: Code CAL
Device class: Class 1
Regulation: 21 CFR 868.5530
Advisory panel: Anesthesiology
Date received: 1987-07-23
Decision date: 1988-01-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Braintree, MA, US

Download summary PDF View on FDA.gov ↗

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K850978 — OLYMPUS LF-1 INTUBATION SCOPE1985-05-23
K802331 — AO FLEXIBLE LARYNGOSCOPE, #LS-71980-10-10

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K062801 — SMARTSUCTION SOLO DEVICE2006-10-04
K061103 — HAEMONETICS 40U RBC FILTER BAG2006-05-17

Adverse events under product code CAL

product code CAL

Malfunction: 885
Total: 885

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.