Atlas FDA

SimuPlus Flexible Annuloplasty Ring, SimuPlus Flexible Annuloplasty Band, SimuForm Semi-Rigid Annuloplasty Ring

FDA 510(k) clearance K201449 · decided 2020-07-01

Clearance details

K-number
K201449
Device name
SimuPlus Flexible Annuloplasty Ring, SimuPlus Flexible Annuloplasty Band, SimuForm Semi-Rigid Annuloplasty Ring
Applicant
Medtronic, Inc.
Decision
Substantially Equivalent
Date received
2020-06-01
Decision date
2020-07-01
Days to decision
30 days
Clearance type
Special
Product code
KRH
Device class
2
Regulation number
870.3800
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Santa Ana, CA, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
MEMO 4D Curve™ Semirigid mitral annuloplasty ring (K261707)Corcym S.r.l.2026-06-18
TriMemo™ SEMIRIGID ANNULOPLASTY RING (K260498)Corcym S.r.l.2026-04-14
Seguin Annuloplasty Ring (K253232)ABBOTT MEDICAL2025-10-29
Edwards MC3 Tricuspid annuloplasty ring (4900) (K251982)Edwards Lifesciences, LLC2025-09-23
Carpentier-Edwards Physio Annuloplasty Ring (4450) (K251688)Edwards Lifesciences, LLC2025-09-17
TransForm McCarthy Mitral Annuloplasty Ring (TF) (K250859)Genesee Biomedical, Inc.2025-07-25
TransForm McCarthy Mitral Annuloplasty Ring (TF) (K232599)Genesee Biomedical, Inc.2024-04-09
WellsForm Tricuspid Annuloplasty Band (WF) (K230679)Genesee Biomedical, Inc.2023-05-26
Memo 3D Semirigid Annuloplasty Ring; Memo 3D ReChord Semirigid Annuloplasty Ring; Memo 4D Semirigid Annuloplasty Ring (K230318)Corcym S.r.l.2023-04-07
TruForm Sievers Annuloplasty Ring (K202253)Genesee Biomedical, Inc.2020-10-06
Physio Flex Annuloplasty Ring (K192762)Edwards Lifesciences, LLC2019-12-16
NeoForm Annuloplasty Ring (K190506)Genesee Biomedical, Inc.2019-04-18

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
SynchroMed Infusion System; Ascenda Intrathecal Catheters (P860004/S455)Medtronic, Inc.2025-12-22
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Percepta Bipolar CRT-P W1TR01 NKE Percepta Quadripolar CRT-P W4TR01 NKE Serena Bipolar CRT-P W1TR02 NKE Serena Quadripol (P010015/S574)Medtronic, Inc.2025-12-19
SynchroMed™ Infusion Systems (P860004/S453)Medtronic, Inc.2025-12-19
Activa Deep Brain Stimulation Therapy System, Percept PC; BrainSense (P960009/S526)Medtronic, Inc.2025-12-18
Activa™ Deep Brain Stimulation Therapy System (P960009/S514)Medtronic, Inc.2025-12-17
Aurora EV-ICD System (P220012/S061)Medtronic, Inc.2025-12-15
Activa™ Deep Brain Stimulation Therapy System, Percept PC/RC BrainSense™ (P960009/S524)Medtronic, Inc.2025-12-08