Reconnaissance PV .018 OTW Digital IVUS Catheter— 510(k) K200410

Name: FDA 510(k) clearance K200410
Creator: U.S. Food and Drug Administration
Published: 2020-05-22

Substantially Equivalent

Philips Image Guided Therapy Corporation

FDA 510(k) clearance K200410 for Reconnaissance PV .018 OTW Digital IVUS Catheter, Substantially Equivalent on 2020-05-22. Applicant: Philips Image Guided Therapy Corporation. Device class: 2.

Clearance details

Applicant: Philips Image Guided Therapy Corporation
Product code: Code OBJ
Device class: Class 2
Regulation: 21 CFR 870.1200
Advisory panel: Cardiovascular
Date received: 2020-02-19
Decision date: 2020-05-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code OBJ

product code OBJ

Death: 38
Injury: 634
Malfunction: 3,453
Total: 4,125

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.