The following data is part of a premarket notification filed by Namic with the FDA for Catheter, Arterial Line.
Device ID | K790083 |
510k Number | K790083 |
Device Name: | CATHETER, ARTERIAL LINE |
Classification | Catheter, Percutaneous |
Applicant | NAMIC 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DQY |
CFR Regulation Number | 870.1250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-01-12 |
Decision Date | 1979-01-25 |