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 | K220626 |
510k Number | K220626 |
Device Name: | Introcan Safety IV Catheter |
Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
Applicant | B.Braun Medical Inc. 901 Marcon Blvd. Allentown, PA 18109 |
Contact | Tracy Larish |
Correspondent | Tracy Larish B.Braun Medical Inc. 901 Marcon Blvd. Allentown, PA 18109 |
Product Code | FOZ |
CFR Regulation Number | 880.5200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2022-03-04 |
Decision Date | 2022-05-14 |