ARROW FLEXBLOCK CONTINUOUS PERIPHERAL NERVE BLOCK CATHETER
FDA 510(k) clearance K122027 · decided 2012-08-28
Clearance details
- K-number
- K122027
- Device name
- ARROW FLEXBLOCK CONTINUOUS PERIPHERAL NERVE BLOCK CATHETER
- Applicant
- Arrow International, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2012-07-11
- Decision date
- 2012-08-28
- Days to decision
- 48 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 |
|---|---|---|
| Description/REF: ACCESS TRAY/ASK-04001-SUH-S; ACCESS TRAY/ASK-04001-VM1; STIMUCATH SFTY KI recall (Z-2364-2026) | ARROW INTERNATIONAL, LLC | 2026-06-13 |