The following data is part of a premarket notification filed by Scimed Life Systems, Inc. with the FDA for Scimed(r) Triduige(r) Guide Catheters.
| Device ID | K946204 |
| 510k Number | K946204 |
| Device Name: | SCIMED(R) TRIDUIGE(R) GUIDE CATHETERS |
| Classification | Catheter, Percutaneous |
| Applicant | SCIMED LIFE SYSTEMS, INC. 8200 SCIMED PLACE Maple Grove, MN 55311 -1566 |
| Contact | Diane M Lowe |
| Correspondent | Diane M Lowe SCIMED LIFE SYSTEMS, INC. 8200 SCIMED PLACE Maple Grove, MN 55311 -1566 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-12-21 |
| Decision Date | 1995-03-13 |