Memo 4D

FDA 510(k) K180411 · Sorin Group Italia S.R.L.

Substantially Equivalent

510(k) numberK180411

Submission

Device name
Memo 4D
Applicant
Sorin Group Italia S.R.L.
Saluggia, IT
Received
February 15, 2018
Decision date
March 16, 2018
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
KRH – Ring, Annuloplasty
Device class
Class II (moderate risk)
Regulation
21 CFR 870.3800
Specialty
Cardiovascular
Implant
Yes

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K250859TransForm McCarthy Mitral Annuloplasty Ring (TF)KRH · Traditional Genesee Biomedical, Inc.07/25/2025SE
K232599TransForm McCarthy Mitral Annuloplasty Ring (TF)KRH · Traditional Genesee Biomedical, Inc.04/09/2024SE
K230679WellsForm Tricuspid Annuloplasty Band (WF)KRH · Traditional Genesee Biomedical, Inc.05/26/2023SE
K230318Memo 3D Semirigid Annuloplasty Ring; Memo 3D ReChord Semirigid Annuloplasty Ring; Memo…KRH · Traditional Corcym S.r.l.04/07/2023SE
K202253TruForm Sievers Annuloplasty RingKRH · Traditional Genesee Biomedical, Inc.10/06/2020SE

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Questions and answers

When was Memo 4D cleared by the FDA?

Memo 4D (K180411) received a 510(k) decision of Substantially Equivalent on March 16, 2018, 29 days after the submission was received.

What is the product code of K180411?

The FDA product code is KRH – Ring, Annuloplasty, a Class II (moderate risk) device regulated under 21 CFR 870.3800.