DIRECTFLOW KIT, 24 FR, SOFTCLAMP KIT, 24FR, STRAIGHTSHOT KIT, 23 FR, STRAIGHT TIP, STRAIGHTSHOT KIT, 23 FR, ANGLED TIP— 510(k) K994243

Substantially Equivalent

Heartport, Inc.

FDA 510(k) clearance K994243 for DIRECTFLOW KIT, 24 FR, SOFTCLAMP KIT, 24FR, STRAIGHTSHOT KIT, 23 FR, STRAIGHT TIP, STRAIGHTSHOT KIT, 23 FR, ANGLED TIP, Substantially Equivalent on 2000-05-05. Applicant: Heartport, Inc..

Clearance details

Applicant: Heartport, Inc.
Product code: Code DWF
Advisory panel: Cardiovascular
Date received: 1999-12-16
Decision date: 2000-05-05
Decision: Substantially Equivalent
Clearance type: Special
Location: Redwood City, CA, US

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Adverse events under product code DWF

product code DWF

Death: 106
Injury: 386
Malfunction: 2,323
Total: 2,815

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.