The following data is part of a premarket notification filed by Scimed with the FDA for Scimed Sideliner.
| Device ID | K922706 |
| 510k Number | K922706 |
| Device Name: | SCIMED SIDELINER |
| Classification | Wire, Guide, Catheter |
| Applicant | SCIMED 6655 WEDGEWOOD RD. Maple Grove, MN 55369 -7503 |
| Contact | Mercedes P Bayani |
| Correspondent | Mercedes P Bayani SCIMED 6655 WEDGEWOOD RD. Maple Grove, MN 55369 -7503 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-06-05 |
| Decision Date | 1992-12-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10193489067040 | K922706 | 000 |
| 20193489078029 | K922706 | 000 |