The following data is part of a premarket notification filed by Exo, Inc. with the FDA for Hemoclav Venous Catheter.
Device ID | K831801 |
510k Number | K831801 |
Device Name: | HEMOCLAV VENOUS CATHETER |
Classification | Cannula, A-v Shunt |
Applicant | EXO, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | FIQ |
CFR Regulation Number | 876.5540 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-06-03 |
Decision Date | 1983-07-07 |