The following data is part of a premarket notification filed by Medway with the FDA for Flex-iv.
Device ID | K911251 |
510k Number | K911251 |
Device Name: | FLEX-IV |
Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
Applicant | MEDWAY 2176 HILLSBORO RD. SUITE 120-362 Franklin, TN 37064 |
Contact | James J Callaway |
Correspondent | James J Callaway MEDWAY 2176 HILLSBORO RD. SUITE 120-362 Franklin, TN 37064 |
Product Code | FOZ |
CFR Regulation Number | 880.5200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-03-21 |
Decision Date | 1991-10-28 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() FLEX-IV 74149871 not registered Dead/Abandoned |
MEDWAY, INC. 1991-03-21 |