The following data is part of a premarket notification filed by Bard Peripheral Vascular, Inc. with the FDA for Bard G2 Filter System - Jugular/subclavian Delivery Kit, Model Rf-320j.
| Device ID | K052578 |
| 510k Number | K052578 |
| Device Name: | BARD G2 FILTER SYSTEM - JUGULAR/SUBCLAVIAN DELIVERY KIT, MODEL RF-320J |
| Classification | Filter, Intravascular, Cardiovascular |
| Applicant | BARD PERIPHERAL VASCULAR, INC. 1415 WEST 3RD ST. Tempe, AZ 85281 |
| Contact | Genevieve Balutowski |
| Correspondent | Genevieve Balutowski BARD PERIPHERAL VASCULAR, INC. 1415 WEST 3RD ST. Tempe, AZ 85281 |
| Product Code | DTK |
| CFR Regulation Number | 870.3375 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-20 |
| Decision Date | 2005-11-25 |
| Summary: | summary |