IS-1 HEMOSTASIS VALVE, MODEL 6799— 510(k) K031398

Name: FDA 510(k) clearance K031398
Creator: U.S. Food and Drug Administration
Published: 2003-05-20

Substantially Equivalent

Guidant Corp.

FDA 510(k) clearance K031398 for IS-1 HEMOSTASIS VALVE, MODEL 6799, Substantially Equivalent on 2003-05-20. Applicant: Guidant Corp.. Device class: 2.

Clearance details

Applicant: Guidant Corp.
Product code: Code DTL
Device class: Class 2
Regulation: 21 CFR 870.4290
Advisory panel: Cardiovascular
Date received: 2003-05-05
Decision date: 2003-05-20
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.