The following data is part of a premarket notification filed by Arrow International, Inc (subsidiary Of Teleflex I with the FDA for Arrow Vps Stylet Plus And Cg+ Arrow Picc Powered By Arrow Vps Stylet Plus.
| Device ID | K141618 |
| 510k Number | K141618 |
| Device Name: | ARROW VPS STYLET PLUS AND CG+ ARROW PICC POWERED BY ARROW VPS STYLET PLUS |
| Classification | Catheter, Ultrasound, Intravascular |
| Applicant | ARROW INTERNATIONAL, INC (SUBSIDIARY OF TELEFLEX I 2400 BERNVILLE ROAD Reading, PA 19605 |
| Contact | Elizabeth Duncan |
| Correspondent | Elizabeth Duncan ARROW INTERNATIONAL, INC (SUBSIDIARY OF TELEFLEX I 2400 BERNVILLE ROAD Reading, PA 19605 |
| Product Code | OBJ |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-06-17 |
| Decision Date | 2014-07-08 |
| Summary: | summary |