FDA cleared the 70 NeuGlide Catheter from Piraeus Medical, Inc. on Sep 4, 2026 under K262277, 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 Jul 6, 2026. The decision came 60 days later, inside the 90 FDA-day goal for a 510(k).
Piraeus Medical, Inc. has one other decision in the tracker over the last 12 months: K260751 (35 Helix Guidewire).
Questions & Answers
What did FDA clear under K262277?
K262277 is the FDA 510(k) for 70 NeuGlide Catheter, submitted by Piraeus Medical, Inc.. FDA's decision date was Sep 4, 2026, under product code QJP (Catheter, Percutaneous, Neurovasculature).
Who makes the 70 NeuGlide Catheter?
Piraeus Medical, Inc., based in Maple Grove, MN, is the applicant of record for K262277. The company is listed in the MedDevice Startups directory.
How long did the K262277 review take?
FDA received the submission on Jul 6, 2026 and issued its decision on Sep 4, 2026, 60 days later.