The following data is part of a premarket notification filed by Scimed Life Systems, Inc. with the FDA for Scimed Encore Advantage Kit And The Essentials Kit.
| Device ID | K951802 |
| 510k Number | K951802 |
| Device Name: | SCIMED ENCORE ADVANTAGE KIT AND THE ESSENTIALS KIT |
| Classification | Injector And Syringe, Angiographic |
| Applicant | SCIMED LIFE SYSTEMS, INC. ONE SCIMED PLACE Maple Grove, MN 55311 -1566 |
| Contact | Diane M Lowe |
| Correspondent | Diane M Lowe SCIMED LIFE SYSTEMS, INC. ONE SCIMED PLACE Maple Grove, MN 55311 -1566 |
| Product Code | DXT |
| CFR Regulation Number | 870.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-04-19 |
| Decision Date | 1995-07-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H74904494102 | K951802 | 000 |
| 20193489078043 | K951802 | 000 |