The following data is part of a premarket notification filed by Scimed Life Systems, Inc. with the FDA for Scimed 6-10 F Triguide Guide Catheters 6f,7f,8f,9f & 10f.
| Device ID | K961280 |
| 510k Number | K961280 |
| Device Name: | SCIMED 6-10 F TRIGUIDE GUIDE CATHETERS 6F,7F,8F,9F & 10F |
| Classification | Catheter, Percutaneous |
| Applicant | SCIMED LIFE SYSTEMS, INC. ONE SCIMED PLACE Maple Grove, MN 55311 -1566 |
| Contact | Angela Raun |
| Correspondent | Angela Raun SCIMED LIFE SYSTEMS, INC. ONE 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 | 1996-04-03 |
| Decision Date | 1996-05-15 |
| Summary: | summary |