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The Tracker / April 2026 / K260938

510(k) cleared

PATH BGC

Crossroads Neurovascular, Inc. · Apr 15, 2026 · K260938

FDA cleared the PATH BGC from Crossroads Neurovascular, Inc. on Apr 15, 2026 under K260938, a special 510(k). The device falls under product code QJP, Catheter, Percutaneous, Neurovasculature, regulated at 21 CFR 870.1250 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Mar 20, 2026. The decision came 26 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Crossroads Neurovascular, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260938?

K260938 is the FDA 510(k) for PATH BGC, submitted by Crossroads Neurovascular, Inc.. FDA's decision date was Apr 15, 2026, under product code QJP (Catheter, Percutaneous, Neurovasculature).

Who makes the PATH BGC?

Crossroads Neurovascular, Inc., based in Lake Forest, CA, is the applicant of record for K260938.

How long did the K260938 review take?

FDA received the submission on Mar 20, 2026 and issued its decision on Apr 15, 2026, 26 days later.

← All decisions in April 2026