The following data is part of a premarket notification filed by Arrow Intl., Inc. with the FDA for Antimicrobial Multi-lumen Central Venous Catheter.
Device ID | K900263 |
510k Number | K900263 |
Device Name: | ANTIMICROBIAL MULTI-LUMEN CENTRAL VENOUS CATHETER |
Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
Applicant | ARROW INTL., INC. P.O. BOX 6306 HILL AND GEORGE AVENUES Reading, PA 19610 |
Contact | Thomas D Nickel |
Correspondent | Thomas D Nickel ARROW INTL., INC. P.O. BOX 6306 HILL AND GEORGE AVENUES Reading, PA 19610 |
Product Code | FOZ |
CFR Regulation Number | 880.5200 [🔎] |
Decision | Substantially Equivalent - Kit (SESK) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-01-18 |
Decision Date | 1990-07-24 |