The following data is part of a premarket notification filed by Deseret Medical, Inc. with the FDA for Deseret Intravascular Catheter.
Device ID | K895734 |
510k Number | K895734 |
Device Name: | DESERET INTRAVASCULAR CATHETER |
Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
Applicant | DESERET MEDICAL, INC. 9450 SOUTH STATE ST. Sandy, UT 84070 |
Contact | Charles J Welle |
Correspondent | Charles J Welle DESERET MEDICAL, INC. 9450 SOUTH STATE ST. Sandy, UT 84070 |
Product Code | FOZ |
CFR Regulation Number | 880.5200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-09-26 |
Decision Date | 1990-04-09 |