The following data is part of a premarket notification filed by Icu Medical, Inc. with the FDA for Posi-link.
Device ID | K000472 |
510k Number | K000472 |
Device Name: | POSI-LINK |
Classification | Set, Administration, Intravascular |
Applicant | ICU MEDICAL, INC. 951 CALLE AMANECER San Clemente, CA 92673 |
Contact | Salvadore F Palomares |
Correspondent | Salvadore F Palomares ICU MEDICAL, INC. 951 CALLE AMANECER San Clemente, CA 92673 |
Product Code | FPA |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-02-14 |
Decision Date | 2000-05-10 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
POSI-LINK 85118782 4106396 Live/Registered |
William P. Nugent Co., Inc. 2010-08-30 |
POSI-LINK 76031521 not registered Dead/Abandoned |
ICU Medical, Inc. 2000-04-20 |
POSI-LINK 74658058 2034375 Dead/Cancelled |
ANSWER PRODUCTS, INC. 1995-04-10 |