The following data is part of a premarket notification filed by B.braun Medical Inc. with the FDA for Introcan Safety 2 Iv Catheter.
| Device ID | K220756 |
| 510k Number | K220756 |
| Device Name: | Introcan Safety 2 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 | 2022-03-15 |
| Decision Date | 2022-06-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04046955746279 | K220756 | 000 |
| 04046955746194 | K220756 | 000 |
| 04046955746118 | K220756 | 000 |
| 04046955746033 | K220756 | 000 |
| 04046955745951 | K220756 | 000 |
| 04046955745876 | K220756 | 000 |
| 04046955745791 | K220756 | 000 |
| 04046955745715 | K220756 | 000 |