HEARTPORT THORACIC TROCAR— 510(k) K964302

Substantially Equivalent

Heartport, Inc.

FDA 510(k) clearance K964302 for HEARTPORT THORACIC TROCAR, Substantially Equivalent on 1997-05-09. Applicant: Heartport, Inc..

Clearance details

Applicant: Heartport, Inc.
Product code: Code DRC
Advisory panel: Cardiovascular
Date received: 1996-10-29
Decision date: 1997-05-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Redwood City, CA, US

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Adverse events under product code DRC

product code DRC

Death: 28
Injury: 412
Total: 440

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.