Atlas FDA

ATTAIN COMMAND 6250 LEFT HEART DELIVERY SYSTEMS AND ATTAIN COMMAND 6250 GUIDE CATHETERS FOR LEFT HEART DELIVERY

FDA 510(k) clearance K080428 · decided 2008-12-09

Clearance details

K-number
K080428
Device name
ATTAIN COMMAND 6250 LEFT HEART DELIVERY SYSTEMS AND ATTAIN COMMAND 6250 GUIDE CATHETERS FOR LEFT HEART DELIVERY
Applicant
Medtronic, Inc.
Decision
Substantially Equivalent
Date received
2008-02-19
Decision date
2008-12-09
Days to decision
294 days
Clearance type
Traditional
Product code
DQY
Device class
2
Regulation number
870.1250
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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SynchroMed™ Infusion Systems (P860004/S453)Medtronic, Inc.2025-12-19
Activa Deep Brain Stimulation Therapy System, Percept PC; BrainSense (P960009/S526)Medtronic, Inc.2025-12-18
Activa™ Deep Brain Stimulation Therapy System (P960009/S514)Medtronic, Inc.2025-12-17
Aurora EV-ICD System (P220012/S061)Medtronic, Inc.2025-12-15
Activa™ Deep Brain Stimulation Therapy System, Percept PC/RC BrainSense™ (P960009/S524)Medtronic, Inc.2025-12-08