The following data is part of a premarket notification filed by Arrow Intl., Inc. with the FDA for Arrowg +ard Blue Plus Antimicrobial Multi-lumen Central Venous Catheter.
Device ID | K993691 |
510k Number | K993691 |
Device Name: | ARROWG +ARD BLUE PLUS ANTIMICROBIAL MULTI-LUMEN CENTRAL VENOUS CATHETER |
Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
Applicant | ARROW INTL., INC. 2400 BERNVILLE RD. Reading, PA 19605 |
Contact | Thomas D Nickel |
Correspondent | Thomas D Nickel ARROW INTL., INC. 2400 BERNVILLE RD. Reading, PA 19605 |
Product Code | FOZ |
CFR Regulation Number | 880.5200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-11-01 |
Decision Date | 2000-03-08 |
Summary: | summary |