MODIFICATION TO ATRIUM MEDICAL CORPORATION CLEARWAY PTFE BALLOON CATHETER— 510(k) K020634

Substantially Equivalent

Atrium Medical Corp.

FDA 510(k) clearance K020634 for MODIFICATION TO ATRIUM MEDICAL CORPORATION CLEARWAY PTFE BALLOON CATHETER, Substantially Equivalent on 2002-05-08. Applicant: Atrium Medical Corp..

Clearance details

Applicant: Atrium Medical Corp.
Product code: Code DXE
Advisory panel: Cardiovascular
Date received: 2002-02-27
Decision date: 2002-05-08
Decision: Substantially Equivalent
Clearance type: Special
Location: Hudson, NH, US

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Adverse events under product code DXE

product code DXE

Death: 27
Injury: 258
Malfunction: 2,266
Total: 2,551

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.