ARROW LARGE-BORE DUAL LUMEN HEMODIALYSIS KIT— 510(k) K895417
Substantially EquivalentArrow Intl., Inc.
FDA 510(k) clearance K895417 for ARROW LARGE-BORE DUAL LUMEN HEMODIALYSIS KIT, Substantially Equivalent on 1990-01-03. Applicant: Arrow Intl., Inc.. Device class: 2.
Clearance details
- Applicant
- Arrow Intl., Inc.
- Product code
- Code LFJ
- 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
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Recalls naming K895417
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 K895417.
Data sourced from openFDA. This site is unofficial and independent of the FDA.