ANTIMICROBIAL MULTI-LUMEN CENTRAL VENOUS CATHETER
FDA 510(k) clearance K900263 · decided 1990-07-24
Clearance details
- K-number
- K900263
- Device name
- ANTIMICROBIAL MULTI-LUMEN CENTRAL VENOUS CATHETER
- Applicant
- Arrow Intl., Inc.
- Decision
- Unknown
- Date received
- 1990-01-18
- Decision date
- 1990-07-24
- Days to decision
- 187 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 Two-Lumen Central Venous Catheterization Set with Blue FlexTip(R) ARROWgard Blue(R) recall (Z-1830-2012) | Arrow International Inc | 2012-06-26 |
| Two-Lumen Central Venous Catheterization Kit with Blue FlexTip ARROWg+ard Blue Catheter recall (Z-2496-2010) | Arrow International Inc | 2010-09-25 |
| Arrow ARROWg+ard CVCs (Central Venous Catheters) recall (Z-1499-2009) | Arrow International Inc | 2009-06-24 |
| Arrow Howes multi-lumen central venous catheterization kit 7 Fr x 20 cm recall (Z-0082-04) | Arrow International Inc | 2003-11-01 |