ANTIMICROBIAL PERITONEAL DIALYSIS COIL CATHETER WITH SPI-ARGENT II— 510(k) K961392

Substantially Equivalent

Sil-Med Corp.

FDA 510(k) clearance K961392 for ANTIMICROBIAL PERITONEAL DIALYSIS COIL CATHETER WITH SPI-ARGENT II, Substantially Equivalent on 1997-07-18. Applicant: Sil-Med Corp..

Clearance details

Applicant: Sil-Med Corp.
Product code: Code FJS
Advisory panel: Gastroenterology, Urology
Date received: 1996-04-11
Decision date: 1997-07-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taunton, MA, US

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Adverse events under product code FJS

product code FJS

Death: 34
Injury: 652
Malfunction: 576
Other: 6
Total: 1,268

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.