The following data is part of a premarket notification filed by Integra Neurocare Llc. with the FDA for Rivetti-levinson Instraluminal Shunt.
| Device ID | K972261 |
| 510k Number | K972261 |
| Device Name: | RIVETTI-LEVINSON INSTRALUMINAL SHUNT |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | INTEGRA NEUROCARE LLC. 8401 102ND ST. SUITE 200-P.O. BOX 390 Pleasant Prairie, WI 53150 -0390 |
| Contact | Lori L Hays |
| Correspondent | Lori L Hays INTEGRA NEUROCARE LLC. 8401 102ND ST. SUITE 200-P.O. BOX 390 Pleasant Prairie, WI 53150 -0390 |
| Product Code | DWF |
| CFR Regulation Number | 870.4210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-06-17 |
| Decision Date | 1997-09-15 |