Atlas FDA

ARTERIAL EMBOLECTOMY

FDA 510(k) clearance K935405 · decided 1994-07-25

Clearance details

K-number
K935405
Device name
ARTERIAL EMBOLECTOMY
Applicant
J-Lloyd Medical, Inc.
Decision
Substantially Equivalent
Date received
1993-11-09
Decision date
1994-07-25
Days to decision
258 days
Clearance type
Traditional
Product code
DXE
Device class
2
Regulation number
870.5150
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
West Berlin, NJ, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.