The following data is part of a premarket notification filed by Teleflex, Inc. with the FDA for Continuous Peripheral Nerve Block Catheter Kit And Set.
| Device ID | K121403 |
| 510k Number | K121403 |
| Device Name: | CONTINUOUS PERIPHERAL NERVE BLOCK CATHETER KIT AND SET |
| Classification | Anesthesia Conduction Kit |
| Applicant | TELEFLEX, INC. 2400 BERNVILLE ROAD Reading, PA 19605 |
| Contact | Paul Amudala |
| Correspondent | Paul Amudala TELEFLEX, INC. 2400 BERNVILLE ROAD Reading, PA 19605 |
| Product Code | CAZ |
| CFR Regulation Number | 868.5140 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-05-10 |
| Decision Date | 2012-06-20 |
| Summary: | summary |