The following data is part of a premarket notification filed by Teleflex Medical , Inc. with the FDA for Ultracath Continuous Nerve Block Catheter.
| Device ID | K162522 |
| 510k Number | K162522 |
| Device Name: | UltraCath Continuous Nerve Block Catheter |
| Classification | Catheter, Conduction, Anesthetic |
| Applicant | TELEFLEX MEDICAL , INC. 3015 Carrington Mill Blvd Morrisville, NC 27560 |
| Contact | James A. Cochie |
| Correspondent | Kristen Bisanz TELEFLEX MEDICAL , INC. 3015 Carrington Mill Blvd Morrisville, NC 27560 |
| Product Code | BSO |
| CFR Regulation Number | 868.5120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-09-09 |
| Decision Date | 2017-03-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30801902134548 | K162522 | 000 |
| 30801902134012 | K162522 | 000 |
| 30801902133992 | K162522 | 000 |
| 40801902134538 | K162522 | 000 |
| 40801902134002 | K162522 | 000 |
| 20801902113768 | K162522 | 000 |