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FDA 510(k) Applications Submitted by CRYOVASCULAR SYSTEMS, INC.
FDA 510(k) Number
Submission Date
Device Name
Applicant
K051916
07/15/2005
POLAR CATH PERIPHERAL DILATATION SYSTEM
CRYOVASCULAR SYSTEMS, INC.
K042230
08/17/2004
POLARCATH PERIPHERAL BALLOON CATHETER SYSTEM
CRYOVASCULAR SYSTEMS, INC.
K042541
09/20/2004
MODIFICATION TO POLARCATH PERIPHERAL DILATATION SYSTEM
CRYOVASCULAR SYSTEMS, INC.
K033622
11/18/2003
POLARCATH PERIPHERAL DILATATION SYSTEM
CRYOVASCULAR SYSTEMS, INC.
K023463
10/15/2002
CVSI PERIPHERAL BALLOON CATHETER; CVSI CATHETER INFLATION UNIT
CRYOVASCULAR SYSTEMS, INC.
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