The following data is part of a premarket notification filed by Meadox Medicals, Div. Boston Scientific Corp. with the FDA for Ms Classique Balloon Catheter W/hydropass Coating.
| Device ID | K953691 |
| 510k Number | K953691 |
| Device Name: | MS CLASSIQUE BALLOON CATHETER W/HYDROPASS COATING |
| Classification | Dilator, Catheter, Ureteral |
| 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 | EZN |
| CFR Regulation Number | 876.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-08-08 |
| Decision Date | 1995-10-16 |