The following data is part of a premarket notification filed by Icu Medical, Inc. with the FDA for Hr(tm) Intravascular Catheter.
| Device ID | K881666 |
| 510k Number | K881666 |
| Device Name: | HR(TM) INTRAVASCULAR CATHETER |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| 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 | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-04-18 |
| Decision Date | 1988-05-06 |