The following data is part of a premarket notification filed by Meadox Medicals, Div. Boston Scientific Corp. with the FDA for Noprofile Olbert Catheter System Balloon Dilatation Catheter.
| Device ID | K953608 |
| 510k Number | K953608 |
| Device Name: | NOPROFILE OLBERT CATHETER SYSTEM BALLOON DILATATION CATHETER |
| Classification | Catheter, Angioplasty, Peripheral, Transluminal |
| Applicant | MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP. 112 BAUER DR. Oakland, NJ 07436 |
| Contact | Stephen B Anderson |
| Correspondent | Stephen B Anderson MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP. 112 BAUER DR. Oakland, NJ 07436 |
| Product Code | LIT |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-08-02 |
| Decision Date | 1995-12-20 |