WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Exit Postmarket & security

THE TAPE

Apollo is in talks to buy J&J's DePuy Synthes for close to $20B BRAINBox signs Prolight to supply the readers for its concussion blood test Intuitive wins a CE mark for transvaginal surgery with the da Vinci SP Beta Bionics clears the Mint patch pump and cuts 2026 guidance the same day J&J sells the Laminar LAA program it bought for $400M upfront in 2023 GE HealthCare is in talks to buy Sofie Biosciences for about $1B Implicity raises $40M to run cardiac implant monitoring across four vendors Boston Scientific says plants and shipping are fully back 17 days after the cyberattack FDA seeks comment on device tracking and raises the burden estimate by 47,526 hours Apollo is in talks to buy J&J's DePuy Synthes for close to $20B BRAINBox signs Prolight to supply the readers for its concussion blood test Intuitive wins a CE mark for transvaginal surgery with the da Vinci SP Beta Bionics clears the Mint patch pump and cuts 2026 guidance the same day J&J sells the Laminar LAA program it bought for $400M upfront in 2023 GE HealthCare is in talks to buy Sofie Biosciences for about $1B Implicity raises $40M to run cardiac implant monitoring across four vendors Boston Scientific says plants and shipping are fully back 17 days after the cyberattack FDA seeks comment on device tracking and raises the burden estimate by 47,526 hours

The Tracker / September 2026 / K260432

510(k) cleared

Ruby Intravascular Catheter

Venocare, Inc. · Sep 2, 2026 · K260432

FDA cleared the Ruby Intravascular Catheter from Venocare, Inc. on Sep 2, 2026 under K260432, a traditional 510(k). The device falls under product code FOZ, Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days, regulated at 21 CFR 880.5200 as a Class 2 device. The review panel was General Hospital.

FDA logged the submission as received on Feb 11, 2026. The decision came 203 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 Venocare, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260432?

K260432 is the FDA 510(k) for Ruby Intravascular Catheter, submitted by Venocare, Inc.. FDA's decision date was Sep 2, 2026, under product code FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days).

Who makes the Ruby Intravascular Catheter?

Venocare, Inc., based in Doral, FL, is the applicant of record for K260432.

How long did the K260432 review take?

FDA received the submission on Feb 11, 2026 and issued its decision on Sep 2, 2026, 203 days later.

← All decisions in September 2026