The following data is part of a premarket notification filed by B. Braun Melsungen Ag with the FDA for Introcan Safety (r) 3 Closed Iv Catheter 18ga X 1-3/4 (45mm) And 18ga X 1-1/4 (32mm) / 20ga X 1-1/4 (32mm) / 20ga X 1.
| Device ID | K111236 |
| 510k Number | K111236 |
| Device Name: | INTROCAN SAFETY (R) 3 CLOSED IV CATHETER 18GA X 1-3/4 (45MM) AND 18GA X 1-1/4 (32MM) / 20GA X 1-1/4 (32MM) / 20GA X 1 |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | B. BRAUN MELSUNGEN AG 901 MARCON BLVD Allentown, PA 18109 |
| Contact | Angela J Caravella |
| Correspondent | Angela J Caravella B. BRAUN MELSUNGEN AG 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 | 2011-05-02 |
| Decision Date | 2011-08-30 |
| Summary: | summary |