Atlas FDA

SOLEX CATHETER, MODEL SL2593

FDA 510(k) clearance K081936 · decided 2008-08-13

Clearance details

K-number
K081936
Device name
SOLEX CATHETER, MODEL SL2593
Applicant
Alsius Corp.
Decision
Substantially Equivalent
Date received
2008-07-07
Decision date
2008-08-13
Days to decision
37 days
Clearance type
Traditional
Product code
NCX
Device class
2
Regulation number
870.5900
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Irvine, CA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.