The following data is part of a premarket notification filed by Lucas Medical, Inc. with the FDA for Lmi Irrigation Catheter (igr).
Device ID | K972623 |
510k Number | K972623 |
Device Name: | LMI IRRIGATION CATHETER (IGR) |
Classification | Catheter, Embolectomy |
Applicant | LUCAS MEDICAL, INC. 1751 SOUTH DOUGLASS RD. Anaheim, CA 92806 |
Contact | Daniel Lucas |
Correspondent | Daniel Lucas LUCAS MEDICAL, INC. 1751 SOUTH DOUGLASS RD. Anaheim, CA 92806 |
Product Code | DXE |
CFR Regulation Number | 870.5150 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-07-14 |
Decision Date | 1997-11-19 |
Summary: | summary |