The following data is part of a premarket notification filed by Hemoshpere, Inc., A Cryolife Company with the FDA for Hero Graft.
| Device ID | K124039 |
| 510k Number | K124039 |
| Device Name: | HERO GRAFT |
| Classification | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter |
| Applicant | HEMOSHPERE, INC., A CRYOLIFE COMPANY 6545 CITY WEST PARKWAY Eden Prairie, MN 55344 |
| Contact | Laurie Lynch |
| Correspondent | Laurie Lynch HEMOSHPERE, INC., A CRYOLIFE COMPANY 6545 CITY WEST PARKWAY Eden Prairie, MN 55344 |
| Product Code | DSY |
| Subsequent Product Code | LJS |
| Subsequent Product Code | MSD |
| CFR Regulation Number | 870.3450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-28 |
| Decision Date | 2013-03-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884450310193 | K124039 | 000 |
| 20884450282865 | K124039 | 000 |
| 10884450282882 | K124039 | 000 |
| 10884450282905 | K124039 | 000 |
| 10884450288969 | K124039 | 000 |
| 10884450288976 | K124039 | 000 |
| 10884450309237 | K124039 | 000 |
| 10884450309244 | K124039 | 000 |
| 10884450310158 | K124039 | 000 |
| 20884450310179 | K124039 | 000 |
| 20884450282841 | K124039 | 000 |