The following data is part of a premarket notification filed by Cathaid, Inc. with the FDA for Tubegripper, Drainage Catheter & Accessory For Su.
Device ID | K864115 |
510k Number | K864115 |
Device Name: | TUBEGRIPPER, DRAINAGE CATHETER & ACCESSORY FOR SU |
Classification | Accessories, Catheter |
Applicant | CATHAID, INC. P.O. BOX 161455 Miami, FL 33116 |
Contact | Howard F Scott |
Correspondent | Howard F Scott CATHAID, INC. P.O. BOX 161455 Miami, FL 33116 |
Product Code | KGZ |
CFR Regulation Number | 878.4200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-10-10 |
Decision Date | 1986-11-07 |