ARROW FLEXBLOCK CONTINUOUS PERIPHERAL NERVE BLOCK CATHETER— 510(k) K122027
Substantially EquivalentArrow International, Inc.
FDA 510(k) clearance K122027 for ARROW FLEXBLOCK CONTINUOUS PERIPHERAL NERVE BLOCK CATHETER, Substantially Equivalent on 2012-08-28. Applicant: Arrow International, Inc.. Device class: 2.
Clearance details
- Applicant
- Arrow International, Inc.
- Product code
- Code CAZ
- Device class
- Class 2
- Regulation
- 21 CFR 868.5140
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Reading, PA, US
Recent devices under product code CAZ
view allMore clearances from Arrow International, Inc.
view allAdverse events under product code CAZ
product code CAZ- Injury
- 145
- Malfunction
- 942
- Other
- 1
- Total
- 1,088
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K122027
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K122027.
Data sourced from openFDA. This site is unofficial and independent of the FDA.