TWO-LUMEN PICC WITH BLUE FLEXTIP CATHETER AND INTEGRAL NEEDLE PROTECTION— 510(k) K003006
Substantially EquivalentArrow Intl., Inc.
FDA 510(k) clearance K003006 for TWO-LUMEN PICC WITH BLUE FLEXTIP CATHETER AND INTEGRAL NEEDLE PROTECTION, Substantially Equivalent on 2000-10-27. Applicant: Arrow Intl., Inc.. Device class: 2.
Clearance details
- Applicant
- Arrow Intl., Inc.
- Product code
- Code LJT
- Device class
- Class 2
- Regulation
- 21 CFR 880.5965
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Reading, PA, US
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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 LJT
product code LJT- Death
- 234
- Injury
- 6,468
- Malfunction
- 5,326
- Other
- 2
- Total
- 12,030
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 K003006
K-number listed on FDA's recall record- Z-2395-2026 — Description/REF: PICC ACCESS TRAY/ASK-04001-CG1
- Z-2825-2015 — Arrow Kits with Medtronic Covidien 0.9% Sodium Chloride Flush Syringes
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K003006.
Data sourced from openFDA. This site is unofficial and independent of the FDA.