The following data is part of a premarket notification filed by B. Braun Medical Inc. with the FDA for Introcan Safety 2 Iv Catheter 18-24 Gauge.
| Device ID | K192676 |
| 510k Number | K192676 |
| Device Name: | Introcan Safety 2 IV Catheter 18-24 Gauge |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-26 |
| Decision Date | 2020-04-01 |