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 |