FDA 510(k)

InVera Infusion Device

K-번호: K250794 · 2026-03-12

결정일2026-03-12

제품 코드KRA

자문 위원회CV

결정Substantially Equivalent

기기 요약

InVera Infusion Device is the device name listed in this FDA 510(k) record. The listed applicant is Invera Medical. It received FDA 510(k) clearance on 2026-03-12 under 510(k) number K250794. The device is classified under product code KRA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the InVera Infusion Device?

InVera Infusion Device is a medical device that received FDA 510(k) clearance on 2026-03-12. The listed applicant is Invera Medical. The 510(k) number is K250794.

When did InVera Infusion Device receive FDA 510(k) clearance?

InVera Infusion Device received FDA 510(k) clearance on 2026-03-12, under 510(k) number K250794.

Who is the listed applicant for InVera Infusion Device?

The FDA 510(k) record lists Invera Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for InVera Infusion Device?

The FDA product code for InVera Infusion Device is KRA.

관련 기기 (코드: KRA)

K253509TriSalus TriNav Advance Infusion SystemTrisalus Life Sciences K254051Extroducer Infusion Catheter SystemSmartWise Sweden AB K261610Verge™ MicrocatheterInstylla, Inc.K260771TruSelect™ 2.6 MicrocatheterBoston Scientific Corporation K243534Micro CatheterSuzhou Zenith Vascular SciTech Limited K231821XO Cath Microcatheter (E20-090-S, E20-110-S, E20-130-S, E20-150-S, E20-175-S, E20-220-S, E20-090-B, E20-110-B, E20-130-B, E20-150-B, E20-175-B, E20-220-B, E26-090-S, E26-110-S, E26-130-S, E26-150-S, E26-175-S, E26-220-S, E26-090-B, E26-110-B, E26-130-B, E26-150-B, E26-175-B, E26-220-B,)Transit Scientific, LLC

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관련 기기 (코드: KRA)

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