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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 / K261696

510(k) cleared

ACUNAV Luxera 4D ICE Catheter

Siemens Medical Solutions USA, Inc. · Sep 10, 2026 · K261696

FDA cleared the ACUNAV Luxera 4D ICE Catheter from Siemens Medical Solutions USA, Inc. on Sep 10, 2026 under K261696, a special 510(k). The device falls under product code OBJ, Catheter, Ultrasound, Intravascular, regulated at 21 CFR 870.1200 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on May 22, 2026. The decision came 111 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Siemens Medical Solutions USA, Inc. has 8 other decisions in the tracker over the last 12 months: K260488 (MULTIX Impact; MULTIX Impact C), K253786 (syngo.CT Coronary Cockpit), K253678 (MAMMOMAT B.brilliant (11372950)), K260844 (ACUSON Sequoia Diagnostic Ultrasound System;ACUSON Sequoia Select Diagnostic Ultrasound System;ACUSON Origin Diagnostic Ultrasound System;ACUSON Origin ICE Diagnostic Ultrasound System).

Questions & Answers

What did FDA clear under K261696?

K261696 is the FDA 510(k) for ACUNAV Luxera 4D ICE Catheter, submitted by Siemens Medical Solutions USA, Inc.. FDA's decision date was Sep 10, 2026, under product code OBJ (Catheter, Ultrasound, Intravascular).

Who makes the ACUNAV Luxera 4D ICE Catheter?

Siemens Medical Solutions USA, Inc., based in Issaquah, WA, is the applicant of record for K261696.

How long did the K261696 review take?

FDA received the submission on May 22, 2026 and issued its decision on Sep 10, 2026, 111 days later.

← All decisions in September 2026