The following data is part of a premarket notification filed by Arrow International Llc Subsidiary Of Teleflex Incorporated with the FDA for Arrow Pressure Injectable Midline Catheter.
| Device ID | K213855 |
| 510k Number | K213855 |
| Device Name: | Arrow Pressure Injectable Midline Catheter |
| Classification | Midline Catheter |
| Applicant | Arrow International LLC Subsidiary Of Teleflex Incorporated 3015 Carrington Mill Blvd Morrisville, NC 27560 |
| Contact | Kim Pennington |
| Correspondent | Kim Pennington Arrow International LLC Subsidiary Of Teleflex Incorporated 3015 Carrington Mill Blvd Morrisville, NC 27560 |
| Product Code | PND |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-12-10 |
| Decision Date | 2022-09-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20801902216834 | K213855 | 000 |
| 20801902216827 | K213855 | 000 |
| 20801902218852 | K213855 | 000 |
| 20801902213086 | K213855 | 000 |
| 20801902213062 | K213855 | 000 |