510(k) K970496— HEARTPORT MAZE SYSTEM: CRYOPROBE SET

Substantially Equivalent

Heartport, Inc.

Clearance details

Applicant: Heartport, Inc.
Product code: Code OCL
Advisory panel: General, Plastic Surgery
Date received: 1997-02-10
Decision date: 1997-05-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Redwood City, CA, US

Adverse events under product code OCL

product code OCL

Death: 34
Injury: 256
Total: 290

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.