HIGH DOSE DISCONNECT CAP AND MINICAP WITH POVIDONE-IODINE, HIGH DOSE DISCONNECT CAP WITH POVIDONE-IODINE— 510(k) K972579

Substantially Equivalent

Baxter Healthcare Corp

FDA 510(k) clearance K972579 for HIGH DOSE DISCONNECT CAP AND MINICAP WITH POVIDONE-IODINE, HIGH DOSE DISCONNECT CAP WITH POVIDONE-IODINE, Substantially Equivalent on 1997-10-01. Applicant: Baxter Healthcare Corp.

Clearance details

Applicant: Baxter Healthcare Corp
Product code: Code KDJ
Advisory panel: Gastroenterology, Urology
Date received: 1997-07-10
Decision date: 1997-10-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mcgaw Park, IL, US

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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.