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FDA approves Cordis Selution SLR, the first sirolimus drug-eluting balloon sold in the US FDA panel takes up GRAIL's Galleri cancer screening PMA on September 23 FDA folds the human factors guidance into eSTAR 7.1 and widens PreSTAR to five more meeting types AVAVA raises $45M with a third of it in debt from its lead investor UpFront Diagnostics wins a CE mark for a 10-minute stroke blood test Ambu pays $45M upfront for TIMS Medical and about 7,000 US hospital installs Citi downgrades Boston Scientific over the cyberattack recovery Autonomix puts Medtronic's former chief regulatory counsel on its board FDA calls the NOxBOXi oxygen leak fix a Class II correction, three years after a Class I recall FDA approves Cordis Selution SLR, the first sirolimus drug-eluting balloon sold in the US FDA panel takes up GRAIL's Galleri cancer screening PMA on September 23 FDA folds the human factors guidance into eSTAR 7.1 and widens PreSTAR to five more meeting types AVAVA raises $45M with a third of it in debt from its lead investor UpFront Diagnostics wins a CE mark for a 10-minute stroke blood test Ambu pays $45M upfront for TIMS Medical and about 7,000 US hospital installs Citi downgrades Boston Scientific over the cyberattack recovery Autonomix puts Medtronic's former chief regulatory counsel on its board FDA calls the NOxBOXi oxygen leak fix a Class II correction, three years after a Class I recall

The Tracker / September 2026 / K261715

510(k) cleared

Emboliner Embolic Protection System (EPC-03)

Emboline, Inc. · Sep 8, 2026 · K261715 · In the directory

FDA cleared the Emboliner Embolic Protection System (EPC-03) from Emboline, Inc. on Sep 8, 2026 under K261715, a traditional 510(k). The device falls under product code PUM, Temporary Catheter, Embolic Protection, Transcatheter Intracardiac Procedures, regulated at 21 CFR 870.1251 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on May 22, 2026. The decision came 109 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 Emboline, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K261715?

K261715 is the FDA 510(k) for Emboliner Embolic Protection System (EPC-03), submitted by Emboline, Inc.. FDA's decision date was Sep 8, 2026, under product code PUM (Temporary Catheter, Embolic Protection, Transcatheter Intracardiac Procedures).

Who makes the Emboliner Embolic Protection System (EPC-03)?

Emboline, Inc., based in Santa Cruz, CA, is the applicant of record for K261715. The company is listed in the MedDevice Startups directory.

How long did the K261715 review take?

FDA received the submission on May 22, 2026 and issued its decision on Sep 8, 2026, 109 days later.

← All decisions in September 2026

Sources

In the startup directory

Emboline

Cardiovascular · Santa Cruz, CA