CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing set (K262398): 510(k) cleared Aug 13, 2026

CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing set

CERENOVUS, Inc. · Aug 13, 2026 · K262398

FDA cleared the CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing set from CERENOVUS, Inc. on Aug 13, 2026 under K262398, a special 510(k). The device falls under product code NRY, Catheter, Thrombus Retriever, regulated at 21 CFR 870.1250 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Jul 14, 2026. The decision came 30 days later, inside the 90 FDA-day goal for a 510(k).

CERENOVUS, Inc. has one other decision in the tracker over the last 12 months: K262419 (MICRUSFRAME (MFR100202); MICRUSFRAME (MFR100253); MICRUSFRAME (MFR100305); MICRUSFRAME (MFR100356); MICRUSFRAME (MFR100407); MICRUSFRAME (MFR100412); MICRUSFRAME (MFR100509); MICRUSFRAME (MFR100517); MICRUSFRAME (MFR100611); MICRUSFRAME (MFR100626); MICRUSFRAME (MFR100713); MICRUSFRAME (MFR100730); MICRUSFRAME (MFR100816); MICRUSFRAME (MFR100829); MICRUSFRAME (MFR140225); MICRUSFRAME (MFR140303); MICRUSFRAME (MFR140304); MICRUSFRAME (MFR140306); MICRUSFRAME (MFR140406); MICRUSFRAME (MF).

Questions & Answers

What did FDA clear under K262398?

K262398 is the FDA 510(k) for CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing set, submitted by CERENOVUS, Inc.. FDA's decision date was Aug 13, 2026, under product code NRY (Catheter, Thrombus Retriever).

Who makes the CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing set?

CERENOVUS, Inc., based in Miami, FL, is the applicant of record for K262398.

How long did the K262398 review take?

FDA received the submission on Jul 14, 2026 and issued its decision on Aug 13, 2026, 30 days later.

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