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 |