The following data is part of a premarket notification filed by Scimed Life Systems, Inc. with the FDA for Scimed 10 Fr Large Lumen Triguide-flex Guid Cath.
| Device ID | K940545 |
| 510k Number | K940545 |
| Device Name: | SCIMED 10 FR LARGE LUMEN TRIGUIDE-FLEX GUID CATH |
| Classification | Catheter, Percutaneous |
| Applicant | SCIMED LIFE SYSTEMS, INC. 2010 EAST CENTER CIRCLE Plymouth, MN 55441 -2644 |
| Contact | Diane M Lowe |
| Correspondent | Diane M Lowe SCIMED LIFE SYSTEMS, INC. 2010 EAST CENTER CIRCLE Plymouth, MN 55441 -2644 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-02-07 |
| Decision Date | 1994-05-06 |