The following data is part of a premarket notification filed by Meadox Medicals, Div. Boston Scientific Corp. with the FDA for Amplatz Guidewires.
| Device ID | K930622 |
| 510k Number | K930622 |
| Device Name: | AMPLATZ GUIDEWIRES |
| Classification | Wire, Guide, Catheter |
| Applicant | MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP. 112 BAUER DR. Oakland, NJ 07436 |
| Contact | Nancy C Koffman |
| Correspondent | Nancy C Koffman MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP. 112 BAUER DR. Oakland, NJ 07436 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-02-08 |
| Decision Date | 1993-04-29 |