DeviceClearance

BLOOD TUBING SETS (STERILE FLUID PATH)— 510(k) K080807

Substantially Equivalent

Nxstage Medical, Inc.

FDA 510(k) clearance K080807 for BLOOD TUBING SETS (STERILE FLUID PATH), Substantially Equivalent on 2008-07-18. Applicant: Nxstage Medical, Inc.. Device class: 2.

Clearance details

Applicant
Nxstage Medical, Inc.
Product code
Code FJK
Device class
Class 2
Regulation
21 CFR 876.5820
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Lawrence, MA, US
Download summary PDFView on FDA.gov ↗

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More clearances from Nxstage Medical, Inc.

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Adverse events under product code FJK

product code FJK
Death
52
Malfunction
3,430
Total
3,482

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 K080807

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 K080807.

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