The following data is part of a premarket notification filed by Scimed Life Systems, Inc. with the FDA for Scimed 6 Fr., 7 Fr., And 8 Fr.,triguide Guiding.
| Device ID | K932420 |
| 510k Number | K932420 |
| Device Name: | SCIMED 6 FR., 7 FR., AND 8 FR.,TRIGUIDE GUIDING |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | SCIMED LIFE SYSTEMS, INC. 6655 WEDGWOOD RD. Maple Grove, MN 55311 -3616 |
| Contact | David A Teicher |
| Correspondent | David A Teicher SCIMED LIFE SYSTEMS, INC. 6655 WEDGWOOD RD. Maple Grove, MN 55311 -3616 |
| Product Code | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-05-19 |
| Decision Date | 1993-08-17 |