Atlas FDA

MEDTRONIC MODEL 3273/3274 RF RECEIVER AND MODEL 3629/3630 SCREENER

FDA 510(k) clearance K972043 · decided 1997-08-22

Clearance details

K-number
K972043
Device name
MEDTRONIC MODEL 3273/3274 RF RECEIVER AND MODEL 3629/3630 SCREENER
Applicant
Medtronic Vascular
Decision
Substantially Equivalent
Date received
1997-06-02
Decision date
1997-08-22
Days to decision
81 days
Clearance type
Traditional
Product code
GZB
Device class
2
Regulation number
882.5880
Medical specialty
Neurology
Advisory committee
Neurology
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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Endurant™ II/IIs Stent Graft System (P100021/S132)Medtronic Vascular2026-05-12
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Endurant™, Endurant™ II/lls Stent Graft System (P100021/S134)Medtronic Vascular2026-02-27
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