The following data is part of a premarket notification filed by Arrow Intl., Inc. with the FDA for Cavity Drainage Catheterization Set, Cs-01600.
| Device ID | K895516 |
| 510k Number | K895516 |
| Device Name: | CAVITY DRAINAGE CATHETERIZATION SET, CS-01600 |
| Classification | Catheter, Irrigation |
| 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 | GBX |
| CFR Regulation Number | 878.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-09-12 |
| Decision Date | 1989-12-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30801902097904 | K895516 | 000 |
| 20801902194002 | K895516 | 000 |
| 20801902125723 | K895516 | 000 |
| 30801902120152 | K895516 | 000 |
| 60801902120153 | K895516 | 000 |
| 50801902120163 | K895516 | 000 |
| 30801902004179 | K895516 | 000 |
| 30801902004810 | K895516 | 000 |
| 30801902004827 | K895516 | 000 |
| 20801902210405 | K895516 | 000 |