The following data is part of a premarket notification filed by Scimed Life Systems, Inc. with the FDA for Scimed 10 Fr. Lg. Lumen Triguide Plus(tm) Guid Cath.
| Device ID | K935654 |
| 510k Number | K935654 |
| Device Name: | SCIMED 10 FR. LG. LUMEN TRIGUIDE PLUS(TM) GUID CATH |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | SCIMED LIFE SYSTEMS, INC. 2010 EAST CENTER CIRCLE Plymouth, MN 55441 -2644 |
| Contact | Deborah L Jensen |
| Correspondent | Deborah L Jensen SCIMED LIFE SYSTEMS, INC. 2010 EAST CENTER CIRCLE Plymouth, MN 55441 -2644 |
| Product Code | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-11-24 |
| Decision Date | 1994-02-22 |