The following data is part of a premarket notification filed by Arrow International, Inc. (subsidiary Of Teleflex Inc.) with the FDA for Arrow Pressure Injectable Midline Catheter With Chlorag+ard Antimicrobial And Antithrombogenic Technology.
| Device ID | K161313 |
| 510k Number | K161313 |
| Device Name: | ARROW Pressure Injectable Midline Catheter With Chlorag+ard Antimicrobial And Antithrombogenic Technology |
| Classification | Midline Catheter |
| Applicant | ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX INC.) 2400 BERNVILLE ROAD Reading, PA 19605 |
| Contact | Julie Lawson |
| Correspondent | Julie Lawson ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX INC.) 2400 BERNVILLE ROAD Reading, PA 19605 |
| Product Code | PND |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2016-05-10 |
| Decision Date | 2016-08-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30801902130168 | K161313 | 000 |
| 20801902137443 | K161313 | 000 |
| 20801902137436 | K161313 | 000 |
| 20801902189350 | K161313 | 000 |
| 20801902188414 | K161313 | 000 |
| 20801902188407 | K161313 | 000 |
| 20801902205494 | K161313 | 000 |
| 20801902205487 | K161313 | 000 |
| 20801902205470 | K161313 | 000 |
| 20801902205463 | K161313 | 000 |
| 00801902201485 | K161313 | 000 |
| 20801902136576 | K161313 | 000 |
| 20801902136583 | K161313 | 000 |
| 20801902144281 | K161313 | 000 |
| 30801902130151 | K161313 | 000 |
| 40801902130165 | K161313 | 000 |
| 40801902130158 | K161313 | 000 |
| 20801902156208 | K161313 | 000 |
| 20801902143123 | K161313 | 000 |
| 20801902133308 | K161313 | 000 |
| 20801902133292 | K161313 | 000 |
| 20801902161363 | K161313 | 000 |
| 20801902158158 | K161313 | 000 |
| 20801902144298 | K161313 | 000 |
| 20801902218869 | K161313 | 000 |