The following data is part of a premarket notification filed by Boston Scientific Corporation with the FDA for Heartstring Iii Proximal Seal System.
| Device ID | K130382 |
| 510k Number | K130382 |
| Device Name: | HEARTSTRING III PROXIMAL SEAL SYSTEM |
| Classification | Clamp, Vascular |
| Applicant | Boston Scientific Corporation 45 BARBOUR POND DRIVE Wayne, NJ 07470 |
| Contact | Mark Dinger |
| Correspondent | Mark Dinger Boston Scientific Corporation 45 BARBOUR POND DRIVE Wayne, NJ 07470 |
| Product Code | DXC |
| CFR Regulation Number | 870.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-02-14 |
| Decision Date | 2013-06-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00607567700321 | K130382 | 000 |
| 00607567700314 | K130382 | 000 |
| 00607567700307 | K130382 | 000 |