The following data is part of a premarket notification filed by Oscor Inc. with the FDA for Introducer, Model Adelante Magnum.
| Device ID | K140917 |
| 510k Number | K140917 |
| Device Name: | INTRODUCER, MODEL ADELANTE MAGNUM |
| Classification | Introducer, Catheter |
| Applicant | Oscor Inc. 3816 DE SOTO BLVD. Palm Harbor, FL 34683 |
| Contact | Laura Sobrin |
| Correspondent | Laura Sobrin Oscor Inc. 3816 DE SOTO BLVD. Palm Harbor, FL 34683 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-04-10 |
| Decision Date | 2014-07-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885672009144 | K140917 | 000 |
| 00885672004750 | K140917 | 000 |
| 00885672004743 | K140917 | 000 |
| 00885672004736 | K140917 | 000 |
| 00885672004729 | K140917 | 000 |
| 00885672004712 | K140917 | 000 |
| 07640168110215 | K140917 | 000 |