GoBack Crossing Catheter— 510(k) K211802

Substantially Equivalent

Upstream Peripheral Technologies, Ltd.

FDA 510(k) clearance K211802 for GoBack Crossing Catheter, Substantially Equivalent on 2022-03-01. Applicant: Upstream Peripheral Technologies, Ltd..

Clearance details

Applicant: Upstream Peripheral Technologies, Ltd.
Product code: Code PDU
Advisory panel: Cardiovascular
Date received: 2021-06-10
Decision date: 2022-03-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Caesarea, IL

Download summary PDF View on FDA.gov ↗

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.