DeviceClearance

14 FR TWO-LUMEN HEMODIALYSIS CATHERIZATION KIT WITH BLUE FLEXTIP ARROWG+ARD BLUE CATHETER FOR HIGH VOLUME INFUSIONS, PRO— 510(k) K993933

Substantially Equivalent

Arrow Intl., Inc.

FDA 510(k) clearance K993933 for 14 FR TWO-LUMEN HEMODIALYSIS CATHERIZATION KIT WITH BLUE FLEXTIP ARROWG+ARD BLUE CATHETER FOR HIGH VOLUME INFUSIONS, PRO, Substantially Equivalent on 2000-09-14. 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
Download summary PDFView on FDA.gov ↗

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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 K993933

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K993933.

Data sourced from openFDA. This site is unofficial and independent of the FDA.