DeviceClearance

Xcela PICC with PASV, Xcela Hybrid PICC with PASV, Xcela Power Injectable PICC— 510(k) K152409

Substantially Equivalent

Navilyst Medical, Inc.

FDA 510(k) clearance K152409 for Xcela PICC with PASV, Xcela Hybrid PICC with PASV, Xcela Power Injectable PICC, Substantially Equivalent on 2015-09-24. Applicant: Navilyst Medical, Inc.. Device class: 2.

Clearance details

Applicant
Navilyst Medical, Inc.
Product code
Code LJS
Device class
Class 2
Regulation
21 CFR 880.5970
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Marlborough, MA, US
Download summary PDFView on FDA.gov ↗

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More clearances from Navilyst Medical, Inc.

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Adverse events under product code LJS

product code LJS
Death
31
Injury
2,791
Malfunction
18,374
Other
5
Total
21,201

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 K152409

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 K152409.

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