The following data is part of a premarket notification filed by Scimed Life Systems, Inc. with the FDA for Scimed(r) Dispatch(tm) Coronary Infusion Catheter.
| Device ID | K932616 |
| 510k Number | K932616 |
| Device Name: | SCIMED(R) DISPATCH(TM) CORONARY INFUSION CATHETER |
| Classification | Catheter, Continuous Flush |
| 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 | KRA |
| CFR Regulation Number | 870.1210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-06-01 |
| Decision Date | 1993-12-15 |