The following data is part of a premarket notification filed by Cordis Corp. with the FDA for Long Medium Palmaz-schatz Balloon Expandable Stent.
| Device ID | K964688 |
| 510k Number | K964688 |
| Device Name: | LONG MEDIUM PALMAZ-SCHATZ BALLOON EXPANDABLE STENT |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | CORDIS CORP. P.O. BOX 4917 35 & 40 TECHNOLOGY DRIVE Warren, NJ 07059 |
| Contact | Joan Martin |
| Correspondent | Joan Martin CORDIS CORP. P.O. BOX 4917 35 & 40 TECHNOLOGY DRIVE Warren, NJ 07059 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-11-22 |
| Decision Date | 1997-06-20 |
| Summary: | summary |