The following data is part of a premarket notification filed by Venusa Ltd. with the FDA for Venusa, Ltd. Extension Set With Filter.
| Device ID | K994429 |
| 510k Number | K994429 |
| Device Name: | VENUSA, LTD. EXTENSION SET WITH FILTER |
| Classification | Set, Administration, Intravascular |
| Applicant | VENUSA LTD. 31C BUTTERFIELD TRAIL El Paso, TX 79906 |
| Contact | Ross Magladry |
| Correspondent | Ross Magladry VENUSA LTD. 31C BUTTERFIELD TRAIL El Paso, TX 79906 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-12-30 |
| Decision Date | 2000-03-03 |
| Summary: | summary |