ANNULOFLO SYSTEM— 510(k) K970375

Name: FDA 510(k) clearance K970375
Creator: U.S. Food and Drug Administration
Published: 1997-07-25

Substantially Equivalent - Subject to Tracking Reg.

Carbomedics, Inc.

FDA 510(k) clearance K970375 for ANNULOFLO SYSTEM, Substantially Equivalent - Subject to Tracking Reg. on 1997-07-25. Applicant: Carbomedics, Inc.. Device class: 2.

Clearance details

Applicant: Carbomedics, Inc.
Product code: Code KRH
Device class: Class 2
Regulation: 21 CFR 870.3800
Advisory panel: Cardiovascular
Date received: 1997-02-03
Decision date: 1997-07-25
Decision: Substantially Equivalent - Subject to Tracking Reg.
Clearance type: Traditional
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code KRH

product code KRH

Death: 45
Injury: 2,235
Total: 2,280

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.