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 | K020785 |
510k Number | K020785 |
Device Name: | INTROCAN SAFETY IV CATHETER |
Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
Applicant | B. BRAUN MEDICAL, INC. 824 TWELFTH AVE. Bethlehem, PA 18018 |
Contact | Amy S Krall |
Correspondent | Amy S Krall B. BRAUN MEDICAL, INC. 824 TWELFTH AVE. Bethlehem, PA 18018 |
Product Code | FOZ |
CFR Regulation Number | 880.5200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-03-11 |
Decision Date | 2002-08-28 |
Summary: | summary |