The following data is part of a premarket notification filed by Health Line International Corporation with the FDA for Health Line Ct Cvc.
| Device ID | K192533 |
| 510k Number | K192533 |
| Device Name: | Health Line CT CVC |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | Health Line International Corporation 5675 W 300 S Salt Lake City, UT 84117 |
| Contact | Joel K. Faulkner |
| Correspondent | Joel K. Faulkner Health Line International Corporation 5675 W 300 S Salt Lake City, UT 84117 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-16 |
| Decision Date | 2019-12-10 |