Atlas FDA

DURAN BAND (MODEL H607H), DURAN RING (MODEL 610R), DURAN BAND (MODEL 610B), DURAN ANCORE RING (MODEL 620R), DURAN ANCORE

FDA 510(k) clearance K032810 · decided 2003-12-05

Clearance details

K-number
K032810
Device name
DURAN BAND (MODEL H607H), DURAN RING (MODEL 610R), DURAN BAND (MODEL 610B), DURAN ANCORE RING (MODEL 620R), DURAN ANCORE
Applicant
Medtronic Heart Valves
Decision
Substantially Equivalent
Date received
2003-09-09
Decision date
2003-12-05
Days to decision
87 days
Clearance type
Traditional
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

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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