The following data is part of a premarket notification filed by Scimed Life Systems, Inc. with the FDA for Scimed Dispatch Gold Coronary Catheter.
| Device ID | K961294 |
| 510k Number | K961294 |
| Device Name: | SCIMED DISPATCH GOLD CORONARY CATHETER |
| Classification | Catheter, Continuous Flush |
| Applicant | SCIMED LIFE SYSTEMS, INC. ONE SCIMED PLACE Maple Grove, MN 55311 -1566 |
| Contact | Deborah A Frank |
| Correspondent | Deborah A Frank SCIMED LIFE SYSTEMS, INC. ONE SCIMED PLACE Maple Grove, MN 55311 -1566 |
| Product Code | KRA |
| CFR Regulation Number | 870.1210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-04 |
| Decision Date | 1996-07-03 |
| Summary: | summary |