STIMUCATH CONTINUOUS NERVE BLOCK SET, MODELS AB-02030, AB-02060, AB-02090, AB-02030-PK, AB-02060-PK, AB-02090-PK
FDA 510(k) clearance K030937 · decided 2003-04-23
Clearance details
- K-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
- Applicant
- Arrow International, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2003-03-25
- Decision date
- 2003-04-23
- Days to decision
- 29 days
- Clearance type
- Special
- Product code
- CAZ
- Device class
- 2
- Regulation number
- 868.5140
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Reading, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Arrow ASK-20608-CMC StimuCath Continuous Nerve Block Kit. Arrow International, Inc. Permit recall (Z-2894-2011) | Arrow International Inc | 2011-07-29 |