Stiletto Extended Dwell Catheter— 510(k) K210047

Name: FDA 510(k) clearance K210047
Creator: U.S. Food and Drug Administration
Published: 2021-08-27

Substantially Equivalent

Piper Access, LLC

FDA 510(k) clearance K210047 for Stiletto Extended Dwell Catheter, Substantially Equivalent on 2021-08-27. Applicant: Piper Access, LLC. Device class: 2.

Clearance details

Applicant: Piper Access, LLC
Product code: Code PND
Device class: Class 2
Regulation: 21 CFR 880.5200
Advisory panel: General Hospital
Date received: 2021-01-08
Decision date: 2021-08-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salt Lake City, UT, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code PND

product code PND

Injury: 149
Malfunction: 695
Other: 1
Total: 845

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.