The following data is part of a premarket notification filed by Arrow International, Inc. with the FDA for Stimucath Continuous Nerve Block Set, Models Ab-02030, Ab-02060, Ab-02090, Ab-02030-pk, Ab-02060-pk, Ab-02090-pk.
| Device ID | K030937 |
| 510k Number | K030937 |
| Device Name: | STIMUCATH CONTINUOUS NERVE BLOCK SET, MODELS AB-02030, AB-02060, AB-02090, AB-02030-PK, AB-02060-PK, AB-02090-PK |
| Classification | Anesthesia Conduction Kit |
| Applicant | ARROW INTERNATIONAL, INC. 2400 BERNVILLE RD. Reading, PA 19605 -9607 |
| Contact | Brandon Epting |
| Correspondent | Brandon Epting ARROW INTERNATIONAL, INC. 2400 BERNVILLE RD. Reading, PA 19605 -9607 |
| Product Code | CAZ |
| CFR Regulation Number | 868.5140 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-03-25 |
| Decision Date | 2003-04-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20801902124719 | K030937 | 000 |
| 30801902126079 | K030937 | 000 |
| 20801902033141 | K030937 | 000 |
| 20801902028093 | K030937 | 000 |
| 20801902136880 | K030937 | 000 |
| 10801902033151 | K030937 | 000 |
| 30801902124709 | K030937 | 000 |
| 40801902128148 | K030937 | 000 |
| 10801902028348 | K030937 | 000 |
| 20801902033110 | K030937 | 000 |