The following data is part of a premarket notification filed by Icu Medical, Inc. with the FDA for Hr Vacutrac.
| Device ID | K881201 |
| 510k Number | K881201 |
| Device Name: | HR VACUTRAC |
| Classification | Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Applicant | ICU MEDICAL, INC. 23436 MADERO ST. Mission Viejo, CA 92691 |
| Contact | Fred Mclendon |
| Correspondent | Fred Mclendon ICU MEDICAL, INC. 23436 MADERO ST. Mission Viejo, CA 92691 |
| Product Code | JKA |
| CFR Regulation Number | 862.1675 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-03-21 |
| Decision Date | 1988-05-16 |