The following data is part of a premarket notification filed by Icu Medical, Inc. with the FDA for Core Resistant Huber Infusion Sets.
| Device ID | K972712 |
| 510k Number | K972712 |
| Device Name: | CORE RESISTANT HUBER INFUSION SETS |
| Classification | Set, Administration, Intravascular |
| Applicant | ICU MEDICAL, INC. 951 CALLE AMANECER San Clemente, CA 92673 |
| Contact | Arlene Dutchik |
| Correspondent | Arlene Dutchik 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 | 1997-07-21 |
| Decision Date | 1997-10-01 |
| Summary: | summary |