The following data is part of a premarket notification filed by Quinton, Inc. with the FDA for Mahurkar Dual Limen Femoral Catheter.
Device ID | K834109 |
510k Number | K834109 |
Device Name: | MAHURKAR DUAL LIMEN FEMORAL CATHETER |
Classification | Catheter, Percutaneous |
Applicant | QUINTON, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | DQY |
CFR Regulation Number | 870.1250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-11-29 |
Decision Date | 1984-02-04 |