ARROWGARD BLUE QUAD-LUMEN CENTRAL VENOUS CATHETER
FDA 510(k) clearance K962577 · decided 1997-08-21
Clearance details
- K-number
- K962577
- Device name
- ARROWGARD BLUE QUAD-LUMEN CENTRAL VENOUS CATHETER
- Applicant
- Arrow Intl., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-07-01
- Decision date
- 1997-08-21
- Days to decision
- 416 days
- Clearance type
- Traditional
- Product code
- FOZ
- Device class
- 2
- Regulation number
- 880.5200
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Reading, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Arrow ARROWg+ard Quad-Lumen CVCs (Central Venous Catheters) recall (Z-1497-2009) | Arrow International Inc | 2009-06-24 |