Medical Device Manufacturer · US , Salt Lake City , UT

Innerdyne, Inc. - FDA 510(k) Cleared Devices

12 submissions · 12 cleared · Since 1995

Recent clearances: INNERDYNE RADIALLY EXPANDING VASCULAR ACCESS SYSTEM (REVAS), INNERDYNE RADIALLY EXPANDING DILATION, RED DEVICE, INNERDYNE GENERIC RADIALLY EXPANDING DILATION, G-RED DEVICE

12

Total

12

Cleared

0

Denied

FDA 510(k) Regulatory Record - Innerdyne, Inc. General & Plastic Surgery ✕

7 devices

1-7 of 7

Cleared May 18, 1999

INNERDYNE GENERIC RADIALLY EXPANDING DILATION, G-RED DEVICE

General & Plastic Surgery · 90d

Cleared Oct 07, 1998

INNERDYNE STEP TROCAR EXPANDABLE PORT, STEP

General & Plastic Surgery · 86d

Cleared Apr 21, 1997

INNERDYNE STEP TROCAR EXPANABLE PORT, OPEN STEP

General & Plastic Surgery · 49d

Cleared Jul 10, 1996

INNERDYNE STEP TROCAR EXPANDABLE PORT, ONESTEP

General & Plastic Surgery · 51d

Cleared May 28, 1996

INNERDYNE STEP TROCAR EXPANDABLE PORT, MINISTEP

General & Plastic Surgery · 43d

Cleared May 12, 1995

INNERDYNE STEP TROCAR EXPANDABLE PORT, STEP

General & Plastic Surgery · 88d

Cleared May 12, 1995

INNERDYNE STEP TROCAR EXPANDABLE PORT, STEP:

General & Plastic Surgery · 88d