Atlas FDA

BIO-PROBE DISPOSABLE INSERT WITH; BALANCE BIOSURFACE, CARMEDA BIOACTIVE SURFACE, TRILLIUM BIOSURFACE

FDA 510(k) clearance K132730 · decided 2014-05-30

Clearance details

K-number
K132730
Device name
BIO-PROBE DISPOSABLE INSERT WITH; BALANCE BIOSURFACE, CARMEDA BIOACTIVE SURFACE, TRILLIUM BIOSURFACE
Applicant
Medtronic, Inc.
Decision
Substantially Equivalent
Date received
2013-09-03
Decision date
2014-05-30
Days to decision
269 days
Clearance type
Traditional
Product code
DPT
Device class
2
Regulation number
870.2120
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

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