XableCath Crossing Catheter— 510(k) K183357

Substantially Equivalent

Xablecath, Inc.

FDA 510(k) clearance K183357 for XableCath Crossing Catheter, Substantially Equivalent on 2019-01-21. Applicant: Xablecath, Inc..

Clearance details

Applicant: Xablecath, Inc.
Product code: Code PDU
Advisory panel: Cardiovascular
Date received: 2018-12-04
Decision date: 2019-01-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salt Lake City, UT, US

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Adverse events under product code PDU

product code PDU

Malfunction: 793
Total: 793

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.