The following data is part of a premarket notification filed by Scimed Peripheral Interventions with the FDA for Scimed(r) Venture(tm) Ii Infusion Catheter.
| Device ID | K945904 |
| 510k Number | K945904 |
| Device Name: | SCIMED(R) VENTURE(TM) II INFUSION CATHETER |
| Classification | Catheter, Continuous Flush |
| Applicant | SCIMED PERIPHERAL INTERVENTIONS ONE SCIMED PLACE Maple Grove, MN 55311 -1566 |
| Contact | Darlene A Thometz |
| Correspondent | Darlene A Thometz SCIMED PERIPHERAL INTERVENTIONS 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 | 1994-12-02 |
| Decision Date | 1995-05-19 |