The following data is part of a premarket notification filed by Teleflex Medical, Inc. with the FDA for Arrow Epidural Catheter Kit.
Device ID | K143581 |
510k Number | K143581 |
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 | 2014-12-18 |
Decision Date | 2015-06-26 |
Summary: | summary |