The following data is part of a premarket notification filed by Oscor Inc. with the FDA for Introducer Sets, Model Adelante Radial.
| Device ID | K130633 |
| 510k Number | K130633 |
| Device Name: | INTRODUCER SETS, MODEL ADELANTE RADIAL |
| Classification | Introducer, Catheter |
| Applicant | Oscor Inc. 3816 DE SOTO BLVD. Palm Harbor, FL 34683 |
| Contact | Mila Doskocil |
| Correspondent | Mila Doskocil 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 | 2013-03-11 |
| Decision Date | 2014-02-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 40888277000712 | K130633 | 000 |
| 10885672003835 | K130633 | 000 |
| 10885672003828 | K130633 | 000 |
| 10885672003811 | K130633 | 000 |
| 10885672003743 | K130633 | 000 |
| 10885672003736 | K130633 | 000 |
| 10885672003729 | K130633 | 000 |
| 10885672002197 | K130633 | 000 |
| 10885672002180 | K130633 | 000 |
| 10885672002173 | K130633 | 000 |
| 10885672002166 | K130633 | 000 |
| 10885672002159 | K130633 | 000 |
| 10885672002142 | K130633 | 000 |
| 10885672000636 | K130633 | 000 |
| 10885672000629 | K130633 | 000 |
| 10885672000612 | K130633 | 000 |
| 10885672000599 | K130633 | 000 |
| 10885672000582 | K130633 | 000 |
| 10885672003842 | K130633 | 000 |
| 10885672003859 | K130633 | 000 |
| 40888277000705 | K130633 | 000 |
| 40888277000699 | K130633 | 000 |
| 20885672004327 | K130633 | 000 |
| 20885672004310 | K130633 | 000 |
| 20885672004303 | K130633 | 000 |
| 20885672003894 | K130633 | 000 |
| 20885672003887 | K130633 | 000 |
| 20885672003870 | K130633 | 000 |
| 20885672000503 | K130633 | 000 |
| 20885672000497 | K130633 | 000 |
| 20885672000480 | K130633 | 000 |
| 10885672103726 | K130633 | 000 |
| 10885672103719 | K130633 | 000 |
| 10885672103665 | K130633 | 000 |
| 10885672006904 | K130633 | 000 |
| 10885672006898 | K130633 | 000 |
| 10885672003866 | K130633 | 000 |
| 10885672000575 | K130633 | 000 |