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The Tracker / September 2026 / K254212

510(k) cleared

NC PTA Balloon Dilatation Catheter

Kossel Medtech (Suzhou) Co., Ltd. · Sep 16, 2026 · K254212

FDA cleared the NC PTA Balloon Dilatation Catheter from Kossel Medtech (Suzhou) Co., Ltd. on Sep 16, 2026 under K254212, a traditional 510(k). The device falls under product code LIT, Catheter, Angioplasty, Peripheral, Transluminal, regulated at 21 CFR 870.1250 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Dec 29, 2025. The decision came 261 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Kossel Medtech (Suzhou) Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K254212?

K254212 is the FDA 510(k) for NC PTA Balloon Dilatation Catheter, submitted by Kossel Medtech (Suzhou) Co., Ltd.. FDA's decision date was Sep 16, 2026, under product code LIT (Catheter, Angioplasty, Peripheral, Transluminal).

Who makes the NC PTA Balloon Dilatation Catheter?

Kossel Medtech (Suzhou) Co., Ltd., based in Suzhou New District, is the applicant of record for K254212.

How long did the K254212 review take?

FDA received the submission on Dec 29, 2025 and issued its decision on Sep 16, 2026, 261 days later.

← All decisions in September 2026