The following data is part of a premarket notification filed by B. Braun Medical, Inc. with the FDA for Intradyn Pediatric Hemostasis Introducer.
| Device ID | K033527 |
| 510k Number | K033527 |
| Device Name: | INTRADYN PEDIATRIC HEMOSTASIS INTRODUCER |
| Classification | Introducer, Catheter |
| Applicant | B. BRAUN MEDICAL, INC. 901 MARCON BLVD. Allentown, PA 18109 -9341 |
| Contact | Amy Smith |
| Correspondent | Amy Smith B. BRAUN MEDICAL, INC. 901 MARCON BLVD. Allentown, PA 18109 -9341 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-11-07 |
| Decision Date | 2004-02-05 |
| Summary: | summary |