The following data is part of a premarket notification filed by Ideas For Medicine, Inc. with the FDA for Versa-cath Arterial Catheter.
Device ID | K961883 |
510k Number | K961883 |
Device Name: | VERSA-CATH ARTERIAL CATHETER |
Classification | Catheter, Embolectomy |
Applicant | IDEAS FOR MEDICINE, INC. 12167-49TH.STREET NORTH Pinellas Park, FL 33520 |
Contact | Elizabeth M Paul |
Correspondent | Elizabeth M Paul IDEAS FOR MEDICINE, INC. 12167-49TH.STREET NORTH Pinellas Park, FL 33520 |
Product Code | DXE |
CFR Regulation Number | 870.5150 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-05-15 |
Decision Date | 1997-01-13 |
Summary: | summary |