PEDIATRIC TWO-LUMEN HEMODIALYSIS CATHERIZATION KIT
FDA 510(k) clearance K984022 · decided 1999-05-18
Clearance details
- K-number
- K984022
- Device name
- PEDIATRIC TWO-LUMEN HEMODIALYSIS CATHERIZATION KIT
- Applicant
- Arrow Intl., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1998-11-12
- Decision date
- 1999-05-18
- Days to decision
- 187 days
- Clearance type
- Traditional
- Product code
- MPB
- Device class
- 2
- Regulation number
- 876.5540
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Reading, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Description/REF: HEMODIALYSIS KIT: 2-LUMEN 8 FR X 11 CM/AK-11802-F; HEMODIALYSIS KIT: 2-LU recall (Z-2373-2026) | ARROW INTERNATIONAL, LLC | 2026-06-13 |