The following data is part of a premarket notification filed by B. Braun Medical, Inc. with the FDA for Perifix One Pediatric Catheter, 20 Ga. & 24 Ga..
| Device ID | K090884 |
| 510k Number | K090884 |
| Device Name: | PERIFIX ONE PEDIATRIC CATHETER, 20 GA. & 24 GA. |
| Classification | Catheter, Conduction, Anesthetic |
| Applicant | B. BRAUN MEDICAL, INC. 901 MARCON BLVD. Allentown, PA 18109 -9341 |
| Contact | Angela J Caravella |
| Correspondent | Angela J Caravella B. BRAUN MEDICAL, INC. 901 MARCON BLVD. Allentown, PA 18109 -9341 |
| Product Code | BSO |
| CFR Regulation Number | 868.5120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-03-31 |
| Decision Date | 2009-06-29 |
| Summary: | summary |