POURCHEZ RETRO TWIN LUMEN CHRONIC HEMODIALYSIS CATHETER WITH SEPARATED TIPS (WITH AND WITHOUT SIDE HOLES)— 510(k) K022000

Substantially Equivalent

Spire Biomedical, Inc.

FDA 510(k) clearance K022000 for POURCHEZ RETRO TWIN LUMEN CHRONIC HEMODIALYSIS CATHETER WITH SEPARATED TIPS (WITH AND WITHOUT SIDE HOLES), Substantially Equivalent on 2002-07-19. Applicant: Spire Biomedical, Inc..

Clearance details

Applicant: Spire Biomedical, Inc.
Product code: Code MSD
Advisory panel: Gastroenterology, Urology
Date received: 2002-06-19
Decision date: 2002-07-19
Decision: Substantially Equivalent
Clearance type: Special
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.