ARROW-HOWES LARGE BORE MULTI-LUMEN CENTRAL VENOUS CATHETERS
FDA 510(k) clearance K970864 · decided 1997-10-17
Clearance details
- K-number
- K970864
- Device name
- ARROW-HOWES LARGE BORE MULTI-LUMEN CENTRAL VENOUS CATHETERS
- Applicant
- Arrow Intl., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-03-10
- Decision date
- 1997-10-17
- Days to decision
- 221 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 |
|---|---|---|
| Description/REF: CVC/PSI KIT: 2 LUMEN 8 FR X 6 IN/ASK-42802-PLH; CVC KIT: 3-LUMEN 12 FR X recall (Z-2376-2026) | ARROW INTERNATIONAL, LLC | 2026-06-13 |
| Arrow Three-Lumen CVC recall (Z-1290-2022) | ARROW INTERNATIONAL Inc. | 2022-06-27 |
| 12 French 3 Lumen 16 cm Large-Bore Central Venous Catheters. Product numbers AK-12123-H, C recall (Z-1671-2009) | Arrow International Inc | 2009-08-10 |
| 12 French 3 Lumen 20 cm Large-Bore Central Venous Catheters. Product numbers AK-15123-H, A recall (Z-1672-2009) | Arrow International Inc | 2009-08-10 |