The following data is part of a premarket notification filed by Pharmacia, Inc. with the FDA for Port-a-cath Implantable Catheter System.
Device ID | K864552 |
510k Number | K864552 |
Device Name: | PORT-A-CATH IMPLANTABLE CATHETER SYSTEM |
Classification | Port & Catheter, Implanted, Subcutaneous, Intraperitoneal |
Applicant | PHARMACIA, INC. 800 CENTENNIAL AVE. Piscataway, NJ 08854 -3911 |
Contact | Albert P Mayo |
Correspondent | Albert P Mayo PHARMACIA, INC. 800 CENTENNIAL AVE. Piscataway, NJ 08854 -3911 |
Product Code | LLD |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-11-19 |
Decision Date | 1987-03-31 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10610586026171 | K864552 | 000 |