The following data is part of a premarket notification filed by Arrow Intl., Inc. with the FDA for Low Profile Port Attachable Catheter With Blue Flex Tip / 8fr. Inroducer Kit Implantable Vascular Access System.
| Device ID | K981782 |
| 510k Number | K981782 |
| Device Name: | LOW PROFILE PORT ATTACHABLE CATHETER WITH BLUE FLEX TIP / 8FR. INRODUCER KIT IMPLANTABLE VASCULAR ACCESS SYSTEM |
| Classification | Introducer, Catheter |
| 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 | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-05-20 |
| Decision Date | 1998-08-12 |