TWO-LUMEN CENTRAL VENOUS ACCESS KIT WITH HEMOSTASIS VALVE/SIDE PORT
FDA 510(k) clearance K002507 · decided 2001-03-21
Clearance details
- K-number
- K002507
- Device name
- TWO-LUMEN CENTRAL VENOUS ACCESS KIT WITH HEMOSTASIS VALVE/SIDE PORT
- Applicant
- Arrow Intl., Inc.
- Decision
- Substantially Equivalent
- Date received
- 2000-08-15
- Decision date
- 2001-03-21
- Days to decision
- 218 days
- Clearance type
- Traditional
- Product code
- DYB
- Device class
- 2
- Regulation number
- 870.1340
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- 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/GU-04020; PSI KIT: 8.5 FR/AK-09803-CDC; PSI KIT: 9 FR/AK-0990 recall (Z-2385-2026) | ARROW INTERNATIONAL, LLC | 2026-06-13 |
| Arrow MAC Two-Lumen Central Venous Access Kit fr use with 7 - 7.5 Fr Catheters, REF ASK-11 recall (Z-0351-2023) | ARROW INTERNATIONAL Inc. | 2022-12-10 |
| Pressure Injectable Arrowg+ard Blue Plus Three-Lumen CVC Kit, REF numbers: a) ASK-42703-NS recall (Z-0352-2023) | ARROW INTERNATIONAL Inc. | 2022-12-10 |
| Arrow Kits with Medtronic Covidien 0.9% Sodium Chloride Flush Syringes recall (Z-2825-2015) | Arrow International Inc | 2015-09-30 |
| MAC Two-Lumen Central Venous Access kit with Integral Hemostasis Valve for use with 7 - 8 recall (Z-2488-2010) | Arrow International Inc | 2010-09-25 |
| Arrow Two-Lumen Central Venous Access (MAC) recall (Z-1496-2009) | Arrow International Inc | 2009-06-24 |