Delivery Catheter SSPC1, Delivery Catheter SSPC2, Delivery Catheter SSPC3, Delivery Catheter SSPC4— 510(k) K190475

Substantially Equivalent

Centerpoint Systems

FDA 510(k) clearance K190475 for Delivery Catheter SSPC1, Delivery Catheter SSPC2, Delivery Catheter SSPC3, Delivery Catheter SSPC4, Substantially Equivalent on 2019-06-28. Applicant: Centerpoint Systems.

Clearance details

Applicant: Centerpoint Systems
Product code: Code DQY
Advisory panel: Cardiovascular
Date received: 2019-02-27
Decision date: 2019-06-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Valley City, UT, US

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Adverse events under product code DQY

product code DQY

Death: 464
Injury: 4,489
Malfunction: 13,721
Other: 2
Total: 18,676

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.