The following data is part of a premarket notification filed by Arrow Intl., Inc. with the FDA for [central Venous][multi-lumen] Catheter W/flex Tip.
Device ID | K862056 |
510k Number | K862056 |
Device Name: | [CENTRAL VENOUS][MULTI-LUMEN] CATHETER W/FLEX TIP |
Classification | Catheter, Percutaneous |
Applicant | ARROW INTL., INC. P.O. BOX 6306 HILL AND GEORGE AVENUES Reading, PA 19610 |
Contact | Ronald P Citron |
Correspondent | Ronald P Citron ARROW INTL., INC. P.O. BOX 6306 HILL AND GEORGE AVENUES Reading, PA 19610 |
Product Code | DQY |
CFR Regulation Number | 870.1250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-05-30 |
Decision Date | 1986-08-25 |