The following data is part of a premarket notification filed by Warner-lambert Co. with the FDA for Multilumen Viapic Central Line Catheter.
Device ID | K861510 |
510k Number | K861510 |
Device Name: | MULTILUMEN VIAPIC CENTRAL LINE CATHETER |
Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
Applicant | WARNER-LAMBERT CO. 9450 SOUTH STATE ST. Sandy, UT 84070 |
Contact | Cleary |
Correspondent | Cleary WARNER-LAMBERT CO. 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 | 1986-04-23 |
Decision Date | 1986-06-09 |