TFX MEDICAL STYLET CATHETER— 510(k) K992664

Substantially Equivalent

Tfx Medical Group

FDA 510(k) clearance K992664 for TFX MEDICAL STYLET CATHETER, Substantially Equivalent on 2000-04-13. Applicant: Tfx Medical Group.

Clearance details

Applicant: Tfx Medical Group
Product code: Code DRB
Advisory panel: Cardiovascular
Date received: 1999-08-09
Decision date: 2000-04-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jeffrey, NH, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DRB

product code DRB

Death: 36
Injury: 562
Total: 598

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.