The following data is part of a premarket notification filed by B. Braun Medical, Inc. with the FDA for Venatech Lp Brachial Introducer System (antecubital).
| Device ID | K063217 |
| 510k Number | K063217 |
| Device Name: | VENATECH LP BRACHIAL INTRODUCER SYSTEM (ANTECUBITAL) |
| Classification | Filter, Intravascular, Cardiovascular |
| Applicant | B. BRAUN MEDICAL, INC. 824 TWELFTH AVE. Bethlehem, PA 18018 |
| Contact | Paul O'connell |
| Correspondent | Paul O'connell B. BRAUN MEDICAL, INC. 824 TWELFTH AVE. Bethlehem, PA 18018 |
| Product Code | DTK |
| CFR Regulation Number | 870.3375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-10-24 |
| Decision Date | 2007-01-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04027478130318 | K063217 | 000 |