The following data is part of a premarket notification filed by Arrow International, Inc. (subsidiary Of Teleflex Inc.) with the FDA for Cg+ Arrow Picc Powered By Arrow Vps Stylet Plus And Arrow Vps Stylet Plus.
| Device ID | K153487 |
| 510k Number | K153487 |
| Device Name: | CG+ Arrow PICC Powered By Arrow VPS Stylet PLUS And Arrow VPS Stylet PLUS |
| Classification | Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days |
| Applicant | ARROW INTERNATIONAL, INC. (Subsidiary Of Teleflex Inc.) 2400 BERNVILLE ROAD Reading, PA 19605 |
| Contact | Elizabeth Duncan |
| Correspondent | Elizabeth Duncan ARROW INTERNATIONAL, INC. (Subsidiary Of Teleflex Inc.) 2400 BERNVILLE ROAD Reading, PA 19605 |
| Product Code | LJS |
| CFR Regulation Number | 880.5970 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-04 |
| Decision Date | 2016-02-04 |
| Summary: | summary |