STIMUCATH CONTINUOUS NERVE BLOCK SET, PRODUCT NUMBER AB-05000
FDA 510(k) clearance K021567 · decided 2002-06-19
Clearance details
- K-number
- K021567
- Device name
- STIMUCATH CONTINUOUS NERVE BLOCK SET, PRODUCT NUMBER AB-05000
- Applicant
- Arrow Intl., Inc.
- Decision
- Substantially Equivalent
- Date received
- 2002-05-13
- Decision date
- 2002-06-19
- Days to decision
- 37 days
- Clearance type
- Traditional
- 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 International StimuCath(R) Continuous Nerve Block Kit, ASK-19608-SFH, Lot # MF012703 recall (Z-0309-2012) | Arrow International Inc | 2011-11-30 |
| Arrow Continuous Nerve Block Needle, Latex-Free* Rx only*Sterile*Arrow International Inc., recall (Z-0852-05) | Arrow International Inc | 2005-06-01 |