The following data is part of a premarket notification filed by Health Line International Corporation with the FDA for Nexus Midline Ct Catheter.
Device ID | K140270 |
510k Number | K140270 |
Device Name: | NEXUS MIDLINE CT CATHETER |
Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
Applicant | HEALTH LINE INTERNATIONAL CORPORATION PO BOX 2786 St. George, UT 84771 -2786 |
Contact | John E Lincoln |
Correspondent | John E Lincoln HEALTH LINE INTERNATIONAL CORPORATION PO BOX 2786 St. George, UT 84771 -2786 |
Product Code | FOZ |
CFR Regulation Number | 880.5200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-02-03 |
Decision Date | 2014-08-20 |
Summary: | summary |