The following data is part of a premarket notification filed by Aesculap Instruments Corp. with the FDA for Protegraft Dv 1500, 1900 & Low Por, Unigraft Dv.
| Device ID | K890182 |
| 510k Number | K890182 |
| Device Name: | PROTEGRAFT DV 1500, 1900 & LOW POR, UNIGRAFT DV |
| Classification | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter |
| Applicant | AESCULAP INSTRUMENTS CORP. 3880 BLACKHAWK DR. Danville, CA 94526 |
| Contact | Dean A Knight |
| Correspondent | Dean A Knight AESCULAP INSTRUMENTS CORP. 3880 BLACKHAWK DR. Danville, CA 94526 |
| Product Code | DSY |
| CFR Regulation Number | 870.3450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-01-18 |
| Decision Date | 1990-02-28 |