The following data is part of a premarket notification filed by Meadox Medicals, Div. Boston Scientific Corp. with the FDA for Olbert Catheter System.
| Device ID | K833616 |
| 510k Number | K833616 |
| Device Name: | OLBERT CATHETER SYSTEM |
| Classification | Catheter, Angioplasty, Peripheral, Transluminal |
| Applicant | MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | LIT |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-10-13 |
| Decision Date | 1983-12-26 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() OLBERT CATHETER SYSTEM 73413748 1336474 Dead/Cancelled |
Surgimed A/S 1983-02-16 |