Lithoplasty Peripheral Balloon Dilatation Catheter, Lithoplasty Generator and Connector Cable, Lithoplasty Connector Cable— 510(k) K161384

Substantially Equivalent

Shockwave Medical, Inc.

FDA 510(k) clearance K161384 for Lithoplasty Peripheral Balloon Dilatation Catheter, Lithoplasty Generator and Connector Cable, Lithoplasty Connector Cable, Substantially Equivalent on 2016-09-14. Applicant: Shockwave Medical, Inc..

Clearance details

Applicant: Shockwave Medical, Inc.
Product code: Code PPN
Advisory panel: Cardiovascular
Date received: 2016-05-19
Decision date: 2016-09-14
Decision: Substantially Equivalent
Clearance type: Traditional
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.