The following data is part of a premarket notification filed by Arrow Intl., Inc. with the FDA for A2 Port, Dual Lumen System With Detached Catheter, Catalog # Ap-01518 (modified).
| Device ID | K963684 |
| 510k Number | K963684 |
| Device Name: | A2 PORT, DUAL LUMEN SYSTEM WITH DETACHED CATHETER, CATALOG # AP-01518 (MODIFIED) |
| Classification | Port & Catheter, Implanted, Subcutaneous, Intravascular |
| Applicant | ARROW INTL., INC. 1600 PROVIDENCE HIGHWAY Walpole, MA 02081 |
| Contact | John D Bonasera |
| Correspondent | John D Bonasera ARROW INTL., INC. 1600 PROVIDENCE HIGHWAY Walpole, MA 02081 |
| Product Code | LJT |
| CFR Regulation Number | 880.5965 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-08-12 |
| Decision Date | 1996-10-24 |