The following data is part of a premarket notification filed by Sangstat Medical Corp. with the FDA for Celsior Cold Flush, Storage And Transport Solution For Hearts.
| Device ID | K991594 |
| 510k Number | K991594 |
| Device Name: | CELSIOR COLD FLUSH, STORAGE AND TRANSPORT SOLUTION FOR HEARTS |
| Classification | System And Accessories, Isolated Heart, Transport And Preservation |
| Applicant | SANGSTAT MEDICAL CORP. 6300 DUMBARTON CIRCLE Fremont, CA 94555 |
| Contact | Eda S Cook |
| Correspondent | Eda S Cook SANGSTAT MEDICAL CORP. 6300 DUMBARTON CIRCLE Fremont, CA 94555 |
| Product Code | MSB |
| CFR Regulation Number | 876.5880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-05-07 |
| Decision Date | 1999-08-05 |
| Summary: | summary |