The following data is part of a premarket notification filed by Quinton, Inc. with the FDA for New Second French Size Mahurkar Catheter.
Device ID | K865096 |
510k Number | K865096 |
Device Name: | NEW SECOND FRENCH SIZE MAHURKAR CATHETER |
Classification | Catheter, Femoral |
Applicant | QUINTON, INC. 2121 TERRY AVE. Seatle, WA 98121 |
Contact | Mary-lee Donoghue |
Correspondent | Mary-lee Donoghue QUINTON, INC. 2121 TERRY AVE. Seatle, WA 98121 |
Product Code | LFK |
CFR Regulation Number | 876.5540 [🔎] |
Decision | Substantially Equivalent - With Drug (SESD) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-12-30 |
Decision Date | 1987-02-18 |