The following data is part of a premarket notification filed by Arrow International, Inc. (subsidiary Of Teleflex Inc.) with the FDA for Arrow Endurance Extended Dwell Peripheral Catheter System.
| Device ID | K152272 |
| 510k Number | K152272 |
| Device Name: | Arrow Endurance Extended Dwell Peripheral Catheter System |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| 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 | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-08-12 |
| Decision Date | 2015-11-23 |
| Summary: | summary |