The following data is part of a premarket notification filed by Lucas Medical, Inc. with the FDA for Lmi Thrombectomy Catheter.
Device ID | K970657 |
510k Number | K970657 |
Device Name: | LMI THROMBECTOMY CATHETER |
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 | 1997-02-21 |
Decision Date | 1997-07-01 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
B3808FTHB800 | K970657 | 000 |
B3803FTHB800 | K970657 | 000 |
B3804FTHB400 | K970657 | 000 |
B3804FTHB800 | K970657 | 000 |
B3805FTHB400 | K970657 | 000 |
B3805FTHB800 | K970657 | 000 |
B3806FTHB400 | K970657 | 000 |
B3806FTHB800 | K970657 | 000 |
B3807FTHB400 | K970657 | 000 |
B3807FTHB800 | K970657 | 000 |
B3808FTHB400 | K970657 | 000 |
B3803FTHB400 | K970657 | 000 |