RAPIDO CUT-A-WAY ROTATING HEMOSTASIS VALVE— 510(k) K031688

Name: FDA 510(k) clearance K031688
Creator: U.S. Food and Drug Administration
Published: 2003-07-02

Substantially Equivalent

Guidant Corporation

FDA 510(k) clearance K031688 for RAPIDO CUT-A-WAY ROTATING HEMOSTASIS VALVE, Substantially Equivalent on 2003-07-02. Applicant: Guidant Corporation. Device class: 2.

Clearance details

Applicant: Guidant Corporation
Product code: Code DTL
Device class: Class 2
Regulation: 21 CFR 870.4290
Advisory panel: Cardiovascular
Date received: 2003-06-02
Decision date: 2003-07-02
Decision: Substantially Equivalent
Clearance type: Special
Location: St Paul, MN, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code DTL

product code DTL

Malfunction: 770
Total: 770

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.