The following data is part of a premarket notification filed by Bard Peripheral Vascular with the FDA for Modification To G2 Filter System-femoral Delivery Kit, Model Rf-310f.
| Device ID | K062887 |
| 510k Number | K062887 |
| Device Name: | MODIFICATION TO G2 FILTER SYSTEM-FEMORAL DELIVERY KIT, MODEL RF-310F |
| Classification | Filter, Intravascular, Cardiovascular |
| Applicant | BARD PERIPHERAL VASCULAR 1625 WEST 3RD ST. PO BOX 1740 Tempe, AZ 85280 -1740 |
| Contact | Genevieve Balutowski |
| Correspondent | Genevieve Balutowski BARD PERIPHERAL VASCULAR 1625 WEST 3RD ST. PO BOX 1740 Tempe, AZ 85280 -1740 |
| Product Code | DTK |
| CFR Regulation Number | 870.3375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-09-26 |
| Decision Date | 2006-10-26 |
| Summary: | summary |