The following data is part of a premarket notification filed by Boston Scientific Corp. with the FDA for Mansfield Cardiac Assist Model 940(tm) Iab.
| Device ID | K904556 |
| 510k Number | K904556 |
| Device Name: | MANSFIELD CARDIAC ASSIST MODEL 940(TM) IAB |
| Classification | Treadmill, Powered |
| Applicant | BOSTON SCIENTIFIC CORP. 2710 ORCHARD PKWY. San Jose, CA 95134 |
| Contact | Jeanne M Lesniak |
| Correspondent | Jeanne M Lesniak BOSTON SCIENTIFIC CORP. 2710 ORCHARD PKWY. San Jose, CA 95134 |
| Product Code | IOL |
| CFR Regulation Number | 890.5380 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-10-05 |
| Decision Date | 1991-12-18 |