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Medtronic pays about $700M for rights to sell Cornerstone Robotics' Sentire outside the US Globus Medical wins a CE mark for Excelsius3D five years after FDA clearance GE HealthCare software updates dropped patients from monitoring, now a Class II recall Boston Scientific pulls Imager II catheters over degrading tips and ends the product line MiniMed wins a CE mark for the Flex insulin pump ahead of its year-end target Boston Scientific restarts shipping a week after the August 25 cyberattack ArthroTAK gets a second 510(k), adding knee tenodesis to its sutureless tendon anchor Oura files S-1 for Nasdaq IPO with $1.21B in nine-month revenue and 5 million paid members FDA confirms a Class I recall of Boston Scientific Infinion CX leads after 1,081 serious injuries Medtronic pays about $700M for rights to sell Cornerstone Robotics' Sentire outside the US Globus Medical wins a CE mark for Excelsius3D five years after FDA clearance GE HealthCare software updates dropped patients from monitoring, now a Class II recall Boston Scientific pulls Imager II catheters over degrading tips and ends the product line MiniMed wins a CE mark for the Flex insulin pump ahead of its year-end target Boston Scientific restarts shipping a week after the August 25 cyberattack ArthroTAK gets a second 510(k), adding knee tenodesis to its sutureless tendon anchor Oura files S-1 for Nasdaq IPO with $1.21B in nine-month revenue and 5 million paid members FDA confirms a Class I recall of Boston Scientific Infinion CX leads after 1,081 serious injuries

The Tracker / August 2026 / K262013

510(k) cleared

Kiba CTO Crossing Catheter

Reflow Medical, Inc. · Aug 28, 2026 · K262013

FDA cleared the Kiba CTO Crossing Catheter from Reflow Medical, Inc. on Aug 28, 2026 under K262013, a special 510(k). The device falls under product code PDU, Catheter For Crossing Total Occlusions, regulated at 21 CFR 870.1250 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Jun 15, 2026. The decision came 74 days later, inside the 90 FDA-day goal for a 510(k).

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

Questions & Answers

What did FDA clear under K262013?

K262013 is the FDA 510(k) for Kiba CTO Crossing Catheter, submitted by Reflow Medical, Inc.. FDA's decision date was Aug 28, 2026, under product code PDU (Catheter For Crossing Total Occlusions).

Who makes the Kiba CTO Crossing Catheter?

Reflow Medical, Inc., based in San Clemente, CA, is the applicant of record for K262013.

How long did the K262013 review take?

FDA received the submission on Jun 15, 2026 and issued its decision on Aug 28, 2026, 74 days later.

← All decisions in August 2026