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FDA 510(k) Applications Submitted by SULZER INTRATHERAPEUTICS, INC.
FDA 510(k) Number
Submission Date
Device Name
Applicant
K020528
02/19/2002
INTRASTENT LD (LARGE DIAMETER) STENT
SULZER INTRATHERAPEUTICS, INC.
K012347
07/24/2001
PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY
SULZER INTRATHERAPEUTICS, INC.
K021563
05/13/2002
INTRACOIL SELF-EXPANDING PERIPHERAL STENT
SULZER INTRATHERAPEUTICS, INC.
K021729
05/24/2002
MODIFICATION TO PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY
SULZER INTRATHERAPEUTICS, INC.
K011806
06/11/2001
PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY
SULZER INTRATHERAPEUTICS, INC.
K012066
07/02/2001
PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY
SULZER INTRATHERAPEUTICS, INC.
K023243
09/30/2002
MODIFICATION TO PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY
SULZER INTRATHERAPEUTICS, INC.
K014136
12/17/2001
MODIFICATION TO PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY
SULZER INTRATHERAPEUTICS, INC.
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