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 |