MiniCap Extended Life PD Transfer Sets— 510(k) K192705

Substantially Equivalent

Baxter Healthcare

FDA 510(k) clearance K192705 for MiniCap Extended Life PD Transfer Sets, Substantially Equivalent on 2019-10-25. Applicant: Baxter Healthcare.

Clearance details

Applicant: Baxter Healthcare
Product code: Code KDJ
Advisory panel: Gastroenterology, Urology
Date received: 2019-09-27
Decision date: 2019-10-25
Decision: Substantially Equivalent
Clearance type: Special
Location: Round Lake, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KDJ

product code KDJ

Death: 298
Injury: 9,221
Malfunction: 8,438
Other: 1
Total: 17,958

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.