15.5FR ALTA GOLD, COATED HEMODIALYSIS CATHETER, MODEL ALC19SH24, ALC23SH28, ALC27SH32, ALC31SH36, ALC35SH40, ALC50SH55— 510(k) K063441

Substantially Equivalent

Spire Biomedical, Inc.

FDA 510(k) clearance K063441 for 15.5FR ALTA GOLD, COATED HEMODIALYSIS CATHETER, MODEL ALC19SH24, ALC23SH28, ALC27SH32, ALC31SH36, ALC35SH40, ALC50SH55, Substantially Equivalent on 2007-02-12. Applicant: Spire Biomedical, Inc..

Clearance details

Applicant: Spire Biomedical, Inc.
Product code: Code MSD
Advisory panel: Gastroenterology, Urology
Date received: 2006-11-14
Decision date: 2007-02-12
Decision: Substantially Equivalent
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.