The following data is part of a premarket notification filed by Arrow Intl., Inc. with the FDA for Arrow Catheter Clamp.
Device ID | K802367 |
510k Number | K802367 |
Device Name: | ARROW CATHETER CLAMP |
Classification | Accessories, Catheter |
Applicant | ARROW INTL., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KGZ |
CFR Regulation Number | 878.4200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-09-29 |
Decision Date | 1980-10-23 |