The following data is part of a premarket notification filed by Arrow International(subsidiary Of Teleflex Inc.) with the FDA for Arrow Jugular Axillo-subclavian Central Catheter (jacc).
| Device ID | K121501 |
| 510k Number | K121501 |
| Device Name: | ARROW JUGULAR AXILLO-SUBCLAVIAN CENTRAL CATHETER (JACC) |
| Classification | Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days |
| 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 | LJS |
| CFR Regulation Number | 880.5970 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-05-21 |
| Decision Date | 2012-11-29 |
| Summary: | summary |