The following data is part of a premarket notification filed by Scimed Life Systems, Inc. with the FDA for Scimed Avenue Coronary Guidewire Insertion Tool.
| Device ID | K922410 |
| 510k Number | K922410 |
| Device Name: | SCIMED AVENUE CORONARY GUIDEWIRE INSERTION TOOL |
| Classification | Wire, Guide, Catheter |
| Applicant | SCIMED LIFE SYSTEMS, INC. 6655 WEDGWOOD RD. Maple Grove, MN 55369 |
| Contact | Mercedes P Bayani |
| Correspondent | Mercedes P Bayani SCIMED LIFE SYSTEMS, INC. 6655 WEDGWOOD RD. Maple Grove, MN 55369 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-05-21 |
| Decision Date | 1992-07-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H96590632449010 | K922410 | 000 |
| H74904490202 | K922410 | 000 |
| 20193489078036 | K922410 | 000 |
| 30193489077661 | K922410 | 000 |