The following data is part of a premarket notification filed by Lucas Medical, Inc. with the FDA for Lmi Arterial Embolectomy Catheter.
| Device ID | K954760 |
| 510k Number | K954760 |
| Device Name: | LMI ARTERIAL EMBOLECTOMY 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 | 1995-10-17 |
| Decision Date | 1996-04-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B3802FEMB600 | K954760 | 000 |
| B380NL2FEMB400 | K954760 | 000 |
| B380NL2FEMB40T0 | K954760 | 000 |
| B380NL2FEMB600 | K954760 | 000 |
| B380NL2FEMB60T0 | K954760 | 000 |
| B380NL3EMB400 | K954760 | 000 |
| B380NL3EMB40T0 | K954760 | 000 |
| B380NL3EMB800 | K954760 | 000 |
| B380NL3EMB80T0 | K954760 | 000 |
| B380NL3FEMB400 | K954760 | 000 |
| B380NL3FEMB40T0 | K954760 | 000 |
| B380NL3FEMB800 | K954760 | 000 |
| B380NL3FEMB80T0 | K954760 | 000 |
| B380NL4EMB1000 | K954760 | 000 |
| B380NL2EMB60T0 | K954760 | 000 |
| B380NL2EMB600 | K954760 | 000 |
| B380NL2EMB40T0 | K954760 | 000 |
| B3802FEMB800 | K954760 | 000 |
| B3803FEMB400 | K954760 | 000 |
| B3803FEMB800 | K954760 | 000 |
| B3804FEMB1000 | K954760 | 000 |
| B3804FEMB400 | K954760 | 000 |
| B3804FEMB800 | K954760 | 000 |
| B3805FEMB400 | K954760 | 000 |
| B3805FEMB800 | K954760 | 000 |
| B3806FEMB400 | K954760 | 000 |
| B3806FEMB800 | K954760 | 000 |
| B3807FEMB400 | K954760 | 000 |
| B3807FEMB800 | K954760 | 000 |
| B380NL2EMB400 | K954760 | 000 |
| B380NL4EMB400 | K954760 | 000 |
| B380NL4EMB40T0 | K954760 | 000 |
| B380NL4EMB800 | K954760 | 000 |
| B380NL6EMB800 | K954760 | 000 |
| B380NL6EMB80T0 | K954760 | 000 |
| B380NL6FEMB400 | K954760 | 000 |
| B380NL6FEMB40T0 | K954760 | 000 |
| B380NL6FEMB800 | K954760 | 000 |
| B380NL6FEMB80T0 | K954760 | 000 |
| B380NL7EMB400 | K954760 | 000 |
| B380NL7EMB40T0 | K954760 | 000 |
| B380NL7EMB800 | K954760 | 000 |
| B380NL7EMB80T0 | K954760 | 000 |
| B380NL7FEMB400 | K954760 | 000 |
| B380NL7FEMB40T0 | K954760 | 000 |
| B380NL7FEMB800 | K954760 | 000 |
| B380NL6EMB40T0 | K954760 | 000 |
| B380NL6EMB400 | K954760 | 000 |
| B380NL5FEMB80T0 | K954760 | 000 |
| B380NL4EMB80T0 | K954760 | 000 |
| B380NL4FEMB1000 | K954760 | 000 |
| B380NL4FEMB400 | K954760 | 000 |
| B380NL4FEMB40T0 | K954760 | 000 |
| B380NL4FEMB800 | K954760 | 000 |
| B380NL4FEMB80T0 | K954760 | 000 |
| B380NL5EMB400 | K954760 | 000 |
| B380NL5EMB40T0 | K954760 | 000 |
| B380NL5EMB800 | K954760 | 000 |
| B380NL5EMB80T0 | K954760 | 000 |
| B380NL5FEMB400 | K954760 | 000 |
| B380NL5FEMB40T0 | K954760 | 000 |
| B380NL5FEMB800 | K954760 | 000 |
| B380NL7FEMB80T0 | K954760 | 000 |