The following data is part of a premarket notification filed by Quinton, Inc. with the FDA for Quinton Mahurkar Catheters W/vitacuff.
Device ID | K895440 |
510k Number | K895440 |
Device Name: | QUINTON MAHURKAR CATHETERS W/VITACUFF |
Classification | Catheter, Percutaneous |
Applicant | QUINTON, INC. 2121 TERRY AVE. Seatle, WA 98121 |
Contact | Donald L Andersen |
Correspondent | Donald L Andersen QUINTON, INC. 2121 TERRY AVE. Seatle, WA 98121 |
Product Code | DQY |
CFR Regulation Number | 870.1250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-09-05 |
Decision Date | 1989-11-29 |