Atlas FDA

CLOSED CHEST SUPPORT CIRCUIT W/BIO-ACTIVE SURFACE

FDA 510(k) clearance K896978 · decided 1990-02-28

Clearance details

K-number
K896978
Device name
CLOSED CHEST SUPPORT CIRCUIT W/BIO-ACTIVE SURFACE
Applicant
Medtronic Vascular
Decision
Substantially Equivalent
Date received
1989-12-13
Decision date
1990-02-28
Days to decision
77 days
Clearance type
Traditional
Product code
DTZ
Device class
2
Regulation number
870.4350
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Anaheim, CA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

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PMA approvals by this applicant

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Valiant Thoracic Stent Graft with the Captivia Delivery System (P100040/S073)Medtronic Vascular2025-06-12
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