The following data is part of a premarket notification filed by Medcanica, Inc. with the FDA for Intercostal Lockable-directable Port.
| Device ID | K011349 |
| 510k Number | K011349 |
| Device Name: | INTERCOSTAL LOCKABLE-DIRECTABLE PORT |
| Classification | Trocar |
| Applicant | MEDCANICA, INC. 19526 EAST LAKE DR. Miami, FL 33015 |
| Contact | Christian L Mazzola |
| Correspondent | Christian L Mazzola MEDCANICA, INC. 19526 EAST LAKE DR. Miami, FL 33015 |
| Product Code | DRC |
| CFR Regulation Number | 870.1390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-05-02 |
| Decision Date | 2001-10-05 |