55CM POURCHEZ RETRO SAFE TRAC TWIN LUMEN HEMODIALYSIS CATHETER MODEL #RS50SH55,RS50NH55,RE50SH55 & RE50NH55— 510(k) K041559

Unknown

Spire Biomedical, Inc.

FDA 510(k) clearance K041559 for 55CM POURCHEZ RETRO SAFE TRAC TWIN LUMEN HEMODIALYSIS CATHETER MODEL #RS50SH55,RS50NH55,RE50SH55 & RE50NH55, Unknown on 2004-07-30. Applicant: Spire Biomedical, Inc..

Clearance details

Applicant: Spire Biomedical, Inc.
Product code: Code MSD
Advisory panel: Gastroenterology, Urology
Date received: 2004-06-10
Decision date: 2004-07-30
Decision: Unknown
Clearance type: Traditional
Location: Bedford, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MSD

product code MSD

Death: 67
Injury: 545
Malfunction: 3,661
Total: 4,273

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.