PEDIATRIC TWO-LUMEN HEMODIALYSIS CATHERIZATION KIT— 510(k) K984022
Substantially EquivalentArrow Intl., Inc.
FDA 510(k) clearance K984022 for PEDIATRIC TWO-LUMEN HEMODIALYSIS CATHERIZATION KIT, Substantially Equivalent on 1999-05-18. Applicant: Arrow Intl., Inc.. Device class: 2.
Clearance details
- Applicant
- Arrow Intl., Inc.
- Product code
- Code MPB
- Device class
- Class 2
- Regulation
- 21 CFR 876.5540
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Reading, PA, US
Recent devices under product code MPB
view all- K250836 — 14F Duo-Flow® Side X Side Double Lumen Catheter
- K200426 — Acute Dual Lumen Hemodialysis Catheter
- K192807 — Duo-Flow Side x Side Double Lumen Catheter
- K192302 — Mahurkar Acute Single Lumen Catheter, Mahurkar Acute Dual Lumen Catheter, Mahurkar Acute Triple Lumen Catheter, Mahurkar Acute High Pressure Triple Lumen Catheter
- K163458 — Zenysis Short-Term Dialysis Catheter
More clearances from Arrow Intl., Inc.
view all- K100635 — ARROWGARD EVOLUTION ANTIMICROBIAL PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) MODEL: S-44041-002, S-45041-002, S-45504
- K093050 — ARROW SELDINGER ARTERIAL CATHERIZATION DEVICES, MODELS EX SAC 00520
- K071491 — ARROW INTERNATIONAL, INC., SURGICAL DRAPES
- K071998 — ARROW ECHOGENIC INTRODUCER NEEDLE COMPONENT
- K071111 — NON-ABSORBABLE SILK SUTURE
Adverse events under product code MPB
product code MPB- Death
- 18
- Malfunction
- 1,042
- Total
- 1,060
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K984022
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K984022.
Data sourced from openFDA. This site is unofficial and independent of the FDA.