The following data is part of a premarket notification filed by Cathaid, Inc. with the FDA for Tubegripper, Drainage Catheter & Accessory For Gu.
| Device ID | K863957 |
| 510k Number | K863957 |
| Device Name: | TUBEGRIPPER, DRAINAGE CATHETER & ACCESSORY FOR GU |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | CATHAID, INC. P.O. BOX 161455 Miami, FL 33116 |
| Contact | Howard F Scott |
| Correspondent | Howard F Scott CATHAID, INC. P.O. BOX 161455 Miami, FL 33116 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-10-10 |
| Decision Date | 1986-10-24 |