The following data is part of a premarket notification filed by Johnson & Johnson Interventional Systems with the FDA for Palmaz(tm) Balloon-expandable Stent, Modification.
| Device ID | K911581 |
| 510k Number | K911581 |
| Device Name: | PALMAZ(TM) BALLOON-EXPANDABLE STENT, MODIFICATION |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | JOHNSON & JOHNSON INTERVENTIONAL SYSTEMS 150 MT. BETHEL RD. P.O. BOX 4917 Warren, NJ 07059 |
| Contact | James P O'donnell |
| Correspondent | James P O'donnell JOHNSON & JOHNSON INTERVENTIONAL SYSTEMS 150 MT. BETHEL RD. P.O. BOX 4917 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 | 1991-04-09 |
| Decision Date | 1991-06-04 |