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 | K163513 |
| 510k Number | K163513 |
| 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 Road Reading, PA 19605 |
| Contact | Fallon Young |
| Correspondent | Fallon Young Arrow International, Inc. (subsidiary Of Teleflex Inc.) 2400 Bernville Road Reading, PA 19605 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-15 |
| Decision Date | 2017-02-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20801902143758 | K163513 | 000 |
| 20801902214229 | K163513 | 000 |
| 20801902215097 | K163513 | 000 |
| 20801902215080 | K163513 | 000 |
| 20801902214205 | K163513 | 000 |
| 20801902214199 | K163513 | 000 |
| 20801902214175 | K163513 | 000 |
| 20801902214168 | K163513 | 000 |
| 20801902214151 | K163513 | 000 |
| 20801902214144 | K163513 | 000 |
| 20801902214137 | K163513 | 000 |
| 20801902214236 | K163513 | 000 |
| 20801902214250 | K163513 | 000 |
| 20801902214267 | K163513 | 000 |
| 20801902193104 | K163513 | 000 |
| 20801902193029 | K163513 | 000 |
| 20801902192985 | K163513 | 000 |
| 20801902133087 | K163513 | 000 |
| 20801902133063 | K163513 | 000 |
| 20801902133049 | K163513 | 000 |
| 20801902133025 | K163513 | 000 |
| 20801902133001 | K163513 | 000 |
| 20801902132981 | K163513 | 000 |
| 20801902215103 | K163513 | 000 |
| 20801902214120 | K163513 | 000 |