14 FR TWO-LUMEN HEMODIALYSIS CATHERIZATION KIT WITH BLUE FLEXTIP ARROWG+ARD BLUE CATHETER FOR HIGH VOLUME INFUSIONS, PRO
FDA 510(k) clearance K993933 · decided 2000-09-14
Clearance details
- K-number
- K993933
- Device name
- 14 FR TWO-LUMEN HEMODIALYSIS CATHERIZATION KIT WITH BLUE FLEXTIP ARROWG+ARD BLUE CATHETER FOR HIGH VOLUME INFUSIONS, PRO
- Applicant
- Arrow Intl., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1999-11-18
- Decision date
- 2000-09-14
- Days to decision
- 301 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 |
| ARROWg+ard Blue Two Lumen Hemodialysis Catheterization Kit for High Volume Infusions; Prod recall (Z-0658-2018) | Arrow International Inc | 2018-02-20 |
| Two Lumen 14F Hemodialysis Catheter Kits/Sets with Blue FlexTip Arrowg+ard Blue Curved Cat recall (Z-0639-04) | Arrow International Inc | 2004-07-20 |