The following data is part of a premarket notification filed by Arrow International, Inc. with the FDA for Arrow Flexblock Continuous Peripheral Nerve Block Catheter.
| Device ID | K122027 |
| 510k Number | K122027 |
| Device Name: | ARROW FLEXBLOCK CONTINUOUS PERIPHERAL NERVE BLOCK CATHETER |
| Classification | Anesthesia Conduction Kit |
| Applicant | ARROW INTERNATIONAL, INC. 2400 BERNVILLE RD. Reading, PA 19605 |
| Contact | Paul Amudala |
| Correspondent | Paul Amudala ARROW INTERNATIONAL, INC. 2400 BERNVILLE RD. Reading, PA 19605 |
| Product Code | CAZ |
| CFR Regulation Number | 868.5140 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-07-11 |
| Decision Date | 2012-08-28 |
| Summary: | summary |