Atlas FDA

MEDTRONIC CONTOUR 3D ANNULOPLASTY RING, MODEL 690R

FDA 510(k) clearance K101212 · decided 2010-08-07

Clearance details

K-number
K101212
Device name
MEDTRONIC CONTOUR 3D ANNULOPLASTY RING, MODEL 690R
Applicant
Medtronic, Inc.
Decision
Substantially Equivalent
Date received
2010-04-30
Decision date
2010-08-07
Days to decision
99 days
Clearance type
Traditional
Product code
KRH
Device class
2
Regulation number
870.3800
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Mounds View, 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

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