Atlas FDA

BIO-CONSOLE, MODEL 560

FDA 510(k) clearance K070286 · decided 2007-05-22

Clearance details

K-number
K070286
Device name
BIO-CONSOLE, MODEL 560
Applicant
Medtronic
Decision
Substantially Equivalent
Date received
2007-01-29
Decision date
2007-05-22
Days to decision
113 days
Clearance type
Traditional
Product code
DWA
Device class
2
Regulation number
870.4380
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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