14 FR. HEMODIALYSIS TWO-LUMEN CATHETERIZATION KIT
FDA 510(k) clearance K991431 · decided 1999-05-26
Clearance details
- K-number
- K991431
- Device name
- 14 FR. HEMODIALYSIS TWO-LUMEN CATHETERIZATION KIT
- Applicant
- Arrow Intl., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1999-04-26
- Decision date
- 1999-05-26
- Days to decision
- 30 days
- Clearance type
- Special
- 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 |
|---|---|---|
| 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 |