The following data is part of a premarket notification filed by Teleflex Medical, Inc. with the FDA for Arrow Epidural Catheter Kit.
| Device ID | K161075 |
| 510k Number | K161075 |
| Device Name: | Arrow Epidural Catheter Kit |
| Classification | Anesthesia Conduction Kit |
| Applicant | TELEFLEX MEDICAL, INC. 3015 CARRINGTON MILL BLVD Morrisville, NC 27560 |
| Contact | Angela Bouse |
| Correspondent | Angela Bouse TELEFLEX MEDICAL, INC. 3015 CARRINGTON MILL BLVD Morrisville, NC 27560 |
| Product Code | CAZ |
| CFR Regulation Number | 868.5140 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-18 |
| Decision Date | 2016-10-04 |
| Summary: | summary |