The following data is part of a premarket notification filed by Arrow Intl., Inc. with the FDA for Low Profile Titanium Port Detached Catheter System Catalog #1037.
| Device ID | K961615 |
| 510k Number | K961615 |
| Device Name: | LOW PROFILE TITANIUM PORT DETACHED CATHETER SYSTEM CATALOG #1037 |
| Classification | Port & Catheter, Implanted, Subcutaneous, Intravascular |
| Applicant | ARROW INTL., INC. 1600 PROVIDENCE HIGHWAY Walpole, MA 02081 |
| Contact | Bradley J Enegren |
| Correspondent | Bradley J Enegren 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 | 1996-04-26 |
| Decision Date | 1996-07-19 |