The following data is part of a premarket notification filed by B.braun Melsungen Ag with the FDA for Introcan Safety 3 Closed Iv Catheter.
| Device ID | K163358 |
| 510k Number | K163358 |
| Device Name: | Introcan Safety 3 Closed IV Catheter |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | B.BRAUN MELSUNGEN AG 1 CARL BRAUN STR. Melsungen, DE 34212 |
| Contact | Ulrich Jedelhauser |
| Correspondent | Kimberly Smith 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 | 2016-11-30 |
| Decision Date | 2017-04-28 |
| Summary: | summary |