FDA 510(k) Applications Submitted by INNERDYNE, INC.

FDA 510(k) Number Submission Date Device Name Applicant
K980578 02/17/1998 INNERDYNE RADIALLY EXPANDING VASCULAR ACCESS SYSTEM (HEPARIN COATED) INNERDYNE, INC.
K990493 02/17/1999 INNERDYNE GENERIC RADIALLY EXPANDING DILATION, G-RED DEVICE INNERDYNE, INC.
K970754 03/03/1997 INNERDYNE STEP TROCAR EXPANABLE PORT, OPEN STEP INNERDYNE, INC.
K990854 03/15/1999 INNERDYNE RADIALLY EXPANDING DILATION, RED DEVICE INNERDYNE, INC.
K971230 04/02/1997 SHERWOOD MEDICAL COMPANY , KANGAROO, ENTRISTAR, PERCUTANEOUS GASTROSTOMY KIT INNERDYNE, INC.
K961430 04/15/1996 INNERDYNE STEP TROCAR EXPANDABLE PORT, MINISTEP INNERDYNE, INC.
K961940 05/20/1996 INNERDYNE STEP TROCAR EXPANDABLE PORT, ONESTEP INNERDYNE, INC.
K982417 07/13/1998 INNERDYNE STEP TROCAR EXPANDABLE PORT, STEP INNERDYNE, INC.
K972684 07/17/1997 INNERDYNE RADIALLY EXPANDING VASCULAR ACCESS SYSTEM INNERDYNE, INC.
K992668 08/09/1999 INNERDYNE RADIALLY EXPANDING VASCULAR ACCESS SYSTEM (REVAS) INNERDYNE, INC.


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