MEMO 3D ReChord

FDA 510(k) K142221 · Sorin Group Italia S.R.L.

Substantially Equivalent

510(k) numberK142221

Submission

Device name
MEMO 3D ReChord
Applicant
Sorin Group Italia S.R.L.
Saluggia Vercelli, IT
Received
August 12, 2014
Decision date
August 29, 2014
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 3D ReChord cleared by the FDA?

MEMO 3D ReChord (K142221) received a 510(k) decision of Substantially Equivalent on August 29, 2014, 17 days after the submission was received.

What is the product code of K142221?

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