Atlas FDA

SIMPLICI-T ANNULOPLASTY SYSTEM

FDA 510(k) clearance K052970 · decided 2006-01-11

Clearance details

K-number
K052970
Device name
SIMPLICI-T ANNULOPLASTY SYSTEM
Applicant
Medtronic Heart Valves
Decision
Substantially Equivalent
Date received
2005-10-24
Decision date
2006-01-11
Days to decision
79 days
Clearance type
Special
Product code
KRH
Device class
2
Regulation number
870.3800
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Minneapolis, MN, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Medtronic Heart Valves

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

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
SimuPlus Flexible Annuloplasty Ring, SimuPlus Flexible Annuloplasty Band, SimuForm Semi-Rigid Annuloplasty Ring (K201449)Medtronic, Inc.2020-07-01
Physio Flex Annuloplasty Ring (K192762)Edwards Lifesciences, LLC2019-12-16

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
Hancock Modified Orifice Valved Conduit (P790007/S067)Medtronic Heart Valves2025-04-16
Hancock Modified Orifice Valved Conduit (P790007/S066)Medtronic Heart Valves2024-04-22
Hancock Modified Orifice Valved Conduit (P790007/S065)Medtronic Heart Valves2023-10-27
Hancock Valved Conduit MO (P790007/S059)Medtronic Heart Valves2022-02-22
Hancock Modified Orifice Valved Conduit (P790007/S063)Medtronic Heart Valves2021-01-05
Hancock Modified Orifice Valved Conduit (P790007/S064)Medtronic Heart Valves2020-12-16
Hancock Valved Conduit Modified Orifice (P790007/S062)Medtronic Heart Valves2019-12-10
Hancock Valved Conduit (P790007/S061)Medtronic Heart Valves2019-07-17