IVS CLIP CLOSURE SYSTEM, MODEL 1002 (IVS CLIP APPLIER); IVS INTRUDUCER SET, MODEL 1001— 510(k) K020879

Substantially Equivalent

Integrated Vascular Systems, Inc.

FDA 510(k) clearance K020879 for IVS CLIP CLOSURE SYSTEM, MODEL 1002 (IVS CLIP APPLIER); IVS INTRUDUCER SET, MODEL 1001, Substantially Equivalent on 2002-09-25. Applicant: Integrated Vascular Systems, Inc..

Clearance details

Applicant: Integrated Vascular Systems, Inc.
Product code: Code FZP
Advisory panel: General, Plastic Surgery
Date received: 2002-03-18
Decision date: 2002-09-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, US

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Adverse events under product code FZP

product code FZP

Death: 11
Injury: 726
Malfunction: 10,830
Other: 1
Total: 11,568

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.