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THE TAPE

Ceribell clears three EEG algorithms under K261712 with no age limit Oura shelves its $2.2B Nasdaq IPO four weeks after filing VCD Medical clears VEnice, a clip that closes varicose veins without heat Sofinnova closes an 82 million euro fund to start six to eight device companies Nyxoah hires former Teleflex CEO Liam Kelly to run the Genio US launch SI-BONE clears Granite Onyx, its first compromised bone implant outside the pelvis Route 92 Medical clears the FreeClimb 46, the smallest catheter in its stroke line Insera clears the CLEAR aspiration system for peripheral clot removal under K253404 Webster Equity takes Lifecore Biomedical private at $6.28 a share plus CVRs Ceribell clears three EEG algorithms under K261712 with no age limit Oura shelves its $2.2B Nasdaq IPO four weeks after filing VCD Medical clears VEnice, a clip that closes varicose veins without heat Sofinnova closes an 82 million euro fund to start six to eight device companies Nyxoah hires former Teleflex CEO Liam Kelly to run the Genio US launch SI-BONE clears Granite Onyx, its first compromised bone implant outside the pelvis Route 92 Medical clears the FreeClimb 46, the smallest catheter in its stroke line Insera clears the CLEAR aspiration system for peripheral clot removal under K253404 Webster Equity takes Lifecore Biomedical private at $6.28 a share plus CVRs

The Directory / Cardiovascular

Cardiovascular

VCD Medical

Brescia, Italy · Unknown · 510(k) cleared

Builds VEnice, a handheld applicator that closes superficial and perforator veins with an implantable clip delivered through a 17-gauge needle under ultrasound guidance. No thermal energy or sclerosant.

FDA DECISIONS ON FILE

1 IN THE TRACKER

Decision	Number	Device	Applicant	Panel	Code
Sep 17, 26	K260677510(k)	Vessel Closure Device (VCD177213P)	Vcd Medical S.R.L.	General, Plastic Surgery	FZP

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VCD Medical

FDA DECISIONS ON FILE

COVERAGE