The following data is part of a premarket notification filed by Ideas For Medicine, Inc. with the FDA for Dural-lumen Intra Vascular Balloon Catheter (modification).
| Device ID | K954713 |
| 510k Number | K954713 |
| Device Name: | DURAL-LUMEN INTRA VASCULAR BALLOON CATHETER (MODIFICATION) |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | IDEAS FOR MEDICINE, INC. 12167 49TH ST. NORTH P.O. BOX 17327 Clearwater, FL 34622 |
| Contact | Elizabeth M Paul |
| Correspondent | Elizabeth M Paul IDEAS FOR MEDICINE, INC. 12167 49TH ST. NORTH P.O. BOX 17327 Clearwater, FL 34622 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-10-10 |
| Decision Date | 1996-07-24 |
| Summary: | summary |