SAM CRRT Unit, SAM Cassette CRRT— 510(k) K170790

Name: FDA 510(k) clearance K170790
Creator: U.S. Food and Drug Administration
Published: 2017-12-13

Substantially Equivalent

Spectral Medical, Inc.

FDA 510(k) clearance K170790 for SAM CRRT Unit, SAM Cassette CRRT, Substantially Equivalent on 2017-12-13. Applicant: Spectral Medical, Inc.. Device class: 2.

Clearance details

Applicant: Spectral Medical, Inc.
Product code: Code KDI
Device class: Class 2
Regulation: 21 CFR 876.5860
Advisory panel: Gastroenterology, Urology
Date received: 2017-03-16
Decision date: 2017-12-13
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Toronto, CA

Download summary PDF View on FDA.gov ↗

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Adverse events under product code KDI

product code KDI

Death: 352
Injury: 1,474
Malfunction: 12,534
Other: 4
Total: 14,364

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.