The following data is part of a premarket notification filed by Arrow International(subsidiary Of Teleflex Inc.) with the FDA for Cg+ Arrow Jacc Powered By Arrow Vps Stylet.
| Device ID | K132133 |
| 510k Number | K132133 |
| Device Name: | CG+ ARROW JACC POWERED BY ARROW VPS STYLET |
| Classification | Catheter, Ultrasound, Intravascular |
| Applicant | ARROW INTERNATIONAL(SUBSIDIARY OF TELEFLEX INC.) 2400 BERNVILLE RD. Reading, PA 19605 |
| Contact | Julie Lawson |
| Correspondent | Julie Lawson ARROW INTERNATIONAL(SUBSIDIARY OF TELEFLEX INC.) 2400 BERNVILLE RD. 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 | 2013-07-11 |
| Decision Date | 2013-09-26 |
| Summary: | summary |