The following data is part of a premarket notification filed by Parke-davis Co. with the FDA for Viapic Central Line Catheter.
Device ID | K860290 |
510k Number | K860290 |
Device Name: | VIAPIC CENTRAL LINE CATHETER |
Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
Applicant | PARKE-DAVIS CO. 870 PARKDALE RD. Rochester, MI 48307 |
Contact | E. F Cleary |
Correspondent | E. F Cleary PARKE-DAVIS CO. 870 PARKDALE RD. Rochester, MI 48307 |
Product Code | FOZ |
CFR Regulation Number | 880.5200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-01-28 |
Decision Date | 1986-03-18 |