The following data is part of a premarket notification filed by Guidant Corporation, Cardiac Surgery with the FDA for Heartstring Iii Proximal Seal System.
| Device ID | K080169 |
| 510k Number | K080169 |
| Device Name: | HEARTSTRING III PROXIMAL SEAL SYSTEM |
| Classification | Clamp, Vascular |
| Applicant | GUIDANT CORPORATION, CARDIAC SURGERY 170 BAYTECH DRIVE San Jose, CA 95134 |
| Contact | Elizabeth Trujillo |
| Correspondent | Ned Devine UNDERWRITERS LABORATORIES, INC. 333 PFINGSTEN RD. Northbrook, IL 60062 |
| Product Code | DXC |
| CFR Regulation Number | 870.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2008-01-24 |
| Decision Date | 2008-02-08 |
| Summary: | summary |