The following data is part of a premarket notification filed by Arrow International ( A Subsidiary Of Teleflex, Inc.) with the FDA for Arrow Pressure Injectable Jugular Axillo-subclavian Central Catheter (jacc) With Sustain Technology.
| Device ID | K150109 |
| 510k Number | K150109 |
| Device Name: | Arrow Pressure Injectable Jugular Axillo-subclavian Central Catheter (JACC) With Sustain Technology |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | Arrow International ( A Subsidiary Of Teleflex, Inc.) 2400 Bernville Rd. Reading, PA 19605 |
| Contact | Karl J Nittinger |
| Correspondent | Karl J Nittinger Arrow International (a Subsidiary Of Teleflex, Inc.) 2400 Bernville Rd. Reading, PA 19605 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-01-20 |
| Decision Date | 2015-06-05 |
| Summary: | summary |