The following data is part of a premarket notification filed by Arrow Internation, Inc. (subsidiary Of Teleflex Inc.) with the FDA for Arrow Endurance Extended Dwell Peripheral Catheter System.
| Device ID | K151513 |
| 510k Number | K151513 |
| Device Name: | Arrow Endurance Extended Dwell Peripheral Catheter System |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | Arrow Internation, Inc. (subsidiary Of Teleflex Inc.) 2400 Bernville Rd Reading, PA 19605 |
| Contact | Tracy Larish |
| Correspondent | Dave Yungvirt THIRD PARTY REVIEW GROUP, LLC 45 ROCKEFELLER PLAZA SUITE 2000 New York, NY 10111 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2015-06-04 |
| Decision Date | 2015-07-08 |
| Summary: | summary |