SUPRACOR BALLOON CATHETER— 510(k) K062582

Substantially Equivalent

Abiomed, Inc.

FDA 510(k) clearance K062582 for SUPRACOR BALLOON CATHETER, Substantially Equivalent on 2006-12-14. Applicant: Abiomed, Inc..

Clearance details

Applicant: Abiomed, Inc.
Product code: Code DSP
Advisory panel: Cardiovascular
Date received: 2006-08-31
Decision date: 2006-12-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Danvers, MA, US

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Adverse events under product code DSP

product code DSP

Death: 317
Injury: 566
Malfunction: 36,831
Other: 4
Total: 37,718

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.