The following data is part of a premarket notification filed by Arrow International, Inc. (subsidiary Of Teleflex Inc.) with the FDA for Arrow Quickflash Arterial Catheterization Device.
| Device ID | K160018 |
| 510k Number | K160018 |
| Device Name: | Arrow Quickflash Arterial Catheterization Device |
| Classification | Wire, Guide, Catheter |
| Applicant | ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX INC.) 2400 BERNVILLE RD Reading, PA 19605 |
| Contact | Tracy Larish |
| Correspondent | Tracy Larish ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX INC.) 2400 BERNVILLE RD Reading, PA 19605 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-01-05 |
| Decision Date | 2016-06-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20801902139416 | K160018 | 000 |
| 20801902136613 | K160018 | 000 |
| 20801902136606 | K160018 | 000 |