The following data is part of a premarket notification filed by Oscor Inc. with the FDA for Safesept Needle Free Transseptal Trocar Guidewire.
| Device ID | K130843 |
| 510k Number | K130843 |
| Device Name: | SAFESEPT NEEDLE FREE TRANSSEPTAL TROCAR GUIDEWIRE |
| Classification | Trocar |
| Applicant | Oscor Inc. 3816 DeSoto Blvd Palm Harbor, FL 34683 |
| Contact | Mila Doskocil |
| Correspondent | Mila Doskocil Oscor Inc. 3816 DeSoto Blvd Palm Harbor, FL 34683 |
| Product Code | DRC |
| CFR Regulation Number | 870.1390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-03-27 |
| Decision Date | 2014-01-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00891492002401 | K130843 | 000 |