The following data is part of a premarket notification filed by Arrow Intl., Inc. with the FDA for 14 Fr. Hemodialysis Two-lumen Catheterization Kit.
| Device ID | K991431 |
| 510k Number | K991431 |
| Device Name: | 14 FR. HEMODIALYSIS TWO-LUMEN CATHETERIZATION KIT |
| Classification | Catheter, Hemodialysis, Non-implanted |
| 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 | MPB |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-04-26 |
| Decision Date | 1999-05-26 |
| Summary: | summary |