The following data is part of a premarket notification filed by B. Braun Medical, Inc. with the FDA for Introcan Safety Iv Catheter.
Device ID | K021094 |
510k Number | K021094 |
Device Name: | INTROCAN SAFETY IV CATHETER |
Classification | Introducer, Catheter |
Applicant | B. BRAUN MEDICAL, INC. 901 MARCON BLVD. Allentown, PA 18109 |
Contact | Patricia D Wilson |
Correspondent | Patricia D Wilson B. BRAUN MEDICAL, INC. 901 MARCON BLVD. Allentown, PA 18109 |
Product Code | DYB |
CFR Regulation Number | 870.1340 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-04-04 |
Decision Date | 2002-07-03 |
Summary: | summary |