The following data is part of a premarket notification filed by Brivant, Ltd. with the FDA for 3 Piece Parodi Guidewire System ( Long Cut Outer With Long Taper .014) Short Taper, 2 Piece Parodi Guidewire System (lon.
| Device ID | K093515 |
| 510k Number | K093515 |
| Device Name: | 3 PIECE PARODI GUIDEWIRE SYSTEM ( LONG CUT OUTER WITH LONG TAPER .014) SHORT TAPER, 2 PIECE PARODI GUIDEWIRE SYSTEM (LON |
| Classification | Wire, Guide, Catheter |
| Applicant | BRIVANT, LTD. PARKMORE WEST BUSINESS PARK Galway, IE |
| Contact | Tomas Furey |
| Correspondent | Tomas Furey BRIVANT, LTD. PARKMORE WEST BUSINESS PARK Galway, IE |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-11-13 |
| Decision Date | 2010-02-16 |
| Summary: | summary |