The following data is part of a premarket notification filed by Parke-davis Co. with the FDA for Deseret Intravascular Catheter.
Device ID | K843033 |
510k Number | K843033 |
Device Name: | DESERET INTRAVASCULAR CATHETER |
Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
Applicant | PARKE-DAVIS CO. 9450 S. STATE ST. Sandy, UT 84070 |
Contact | Clearly |
Correspondent | Clearly PARKE-DAVIS CO. 9450 S. 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 | 1984-08-01 |
Decision Date | 1984-12-03 |