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510(k) K050645

CORDIS AMIIA .014 PTA BALLOON CATHETER by Cordis Corp. — Product Code LIT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 1, 2005
Date Received
March 14, 2005
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Angioplasty, Peripheral, Transluminal
Device Class
Class II
Regulation Number
870.1250
Review Panel
CV
Submission Type

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