510(k) K122873

VASOPOUSE DEEP VEIN THROMBOSIS COMPRESSION DEVICE MODEL IPCS, MODEL SQS by Caremed Supply, Inc. — Product Code JOW

K122873 is an FDA 510(k) premarket notification submitted by Caremed Supply, Inc. for the device "VASOPOUSE DEEP VEIN THROMBOSIS COMPRESSION DEVICE MODEL IPCS, MODEL SQS". The FDA issued a decision of Substantially Equivalent on Jan 15, 2013. The device falls under product code JOW (Sleeve, Limb, Compressible), a Class II device regulated under 21 CFR 870.5800. Caremed Supply, Inc. has 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Jan 15, 2013
Date Received
Sep 19, 2012
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sleeve, Limb, Compressible
Device Class
Class II
Regulation Number
870.5800
Review Panel
CV
Submission Type
510(k)