The following data is part of a premarket notification filed by Hdc Corp. with the FDA for Ven-a-cath Percutaneous Venous Catheter Kit.
Device ID | K881504 |
510k Number | K881504 |
Device Name: | VEN-A-CATH PERCUTANEOUS VENOUS CATHETER KIT |
Classification | Catheter, Percutaneous |
Applicant | HDC CORP. 2551 CASEY AVE. Mountain View, CA 94043 |
Contact | Ronald L Coleman |
Correspondent | Ronald L Coleman HDC CORP. 2551 CASEY AVE. Mountain View, CA 94043 |
Product Code | DQY |
CFR Regulation Number | 870.1250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-04-11 |
Decision Date | 1988-06-22 |