GoBack Crossing Catheter— 510(k) K211802

Name: FDA 510(k) clearance K211802
Creator: U.S. Food and Drug Administration
Published: 2022-03-01

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.. Device class: 2.

Clearance details

Applicant: Upstream Peripheral Technologies, Ltd.
Product code: Code PDU
Device class: Class 2
Regulation: 21 CFR 870.1250
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 ↗

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K182937 — Upstream GoBack Crossing Catheter2019-05-23

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.