Tunnel Crossing Catheter— 510(k) K221163

Name: FDA 510(k) clearance K221163
Creator: U.S. Food and Drug Administration
Published: 2023-01-19

Substantially Equivalent

Tractus Vascular, LLC

FDA 510(k) clearance K221163 for Tunnel Crossing Catheter, Substantially Equivalent on 2023-01-19. Applicant: Tractus Vascular, LLC. Device class: 2.

Clearance details

Applicant: Tractus Vascular, LLC
Product code: Code PDU
Device class: Class 2
Regulation: 21 CFR 870.1250
Advisory panel: Cardiovascular
Date received: 2022-04-22
Decision date: 2023-01-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Eatontown, NJ, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code PDU

product code PDU

Malfunction: 793
Total: 793

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.