Lithoplasty Peripheral Balloon Dilatation Catheter; Lithoplasty Generator And Connector Cable; Lithoplasty Connector Cable— 510(k) K163306

Substantially Equivalent

Shockwave Medical, Inc.

FDA 510(k) clearance K163306 for Lithoplasty Peripheral Balloon Dilatation Catheter; Lithoplasty Generator And Connector Cable; Lithoplasty Connector Cable, Substantially Equivalent on 2016-12-22. Applicant: Shockwave Medical, Inc..

Clearance details

Applicant: Shockwave Medical, Inc.
Product code: Code PPN
Advisory panel: Cardiovascular
Date received: 2016-11-23
Decision date: 2016-12-22
Decision: Substantially Equivalent
Clearance type: Special
Location: Fremont, CA, US

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Adverse events under product code PPN

product code PPN

Death: 16
Total: 16

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.