The following data is part of a premarket notification filed by B.braun Interventional Systems Inc. with the FDA for Venatech Convertible Vena Cava Filter System.
| Device ID | K152765 |
| 510k Number | K152765 |
| Device Name: | VENATECH CONVERTIBLE VENA CAVA FILTER SYSTEM |
| Classification | Filter, Intravascular, Cardiovascular |
| Applicant | B.BRAUN INTERVENTIONAL SYSTEMS INC. 824 TWELFTH AVENUE Bethlehem, PA 18018 |
| Contact | Peter Flosdorf |
| Correspondent | Peter Flosdorf B.BRAUN INTERVENTIONAL SYSTEMS INC. 824 TWELFTH AVENUE 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 | 2015-09-24 |
| Decision Date | 2016-02-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04027478130752 | K152765 | 000 |