The following data is part of a premarket notification filed by Arrow International, Inc. (subsidiary Of Teleflex Inc.) with the FDA for Multi-lumen Acute Hemodialysis Catheter For High Volume Infusions.
| Device ID | K143102 |
| 510k Number | K143102 |
| Device Name: | Multi-Lumen Acute Hemodialysis Catheter For High Volume Infusions |
| Classification | Catheter, Hemodialysis, Triple Lumen, Non-implanted |
| Applicant | Arrow International, Inc. (Subsidiary Of Teleflex Inc.) 2400 Bernville Road Reading, PA 19605 |
| Contact | Debra Grodt |
| Correspondent | Karl J Nittinger Arrow International, Inc. (Subsidiary Of Teleflex Inc.) 2400 Bernville Road Reading, PA 19605 |
| Product Code | NIE |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent - Kit With Drugs (SEKD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-10-29 |
| Decision Date | 2015-07-24 |
| Summary: | summary |