The following data is part of a premarket notification filed by Ideas For Medicine, Inc. with the FDA for Pruitt Vascular Shunt.
Device ID | K801359 |
510k Number | K801359 |
Device Name: | PRUITT VASCULAR SHUNT |
Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
Applicant | IDEAS FOR MEDICINE, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | DWF |
CFR Regulation Number | 870.4210 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-06-09 |
Decision Date | 1980-07-28 |