Cleared Special

K111906 - XCELA HYBRID PICC WITH PASV VALVE TECHN...

K111906 is the FDA 510(k) clearance for XCELA HYBRID PICC WITH PASV VALVE TECHN... by Navilyst Medical, Inc.. It is a Class 2 General Hospital device (product code LJS) cleared through the Special 510(k) pathway after a 24-day FDA review.

K111906 · Navilyst Medical, Inc. · General Hospital
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Jul 2011
Decision
24d
Days
Class 2
Risk

K111906 is an FDA 510(k) clearance for the XCELA HYBRID PICC WITH PASV VALVE TECHNOLOGY. Classified as Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (product code LJS), Class II - Special Controls.

Submitted by Navilyst Medical, Inc. (Marlborough, US). The FDA issued a Cleared decision on July 29, 2011 after a review of 24 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5970 - the FDA general hospital device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Navilyst Medical, Inc. devices

Submission Details

510(k) Number K111906 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 2011
Decision Date July 29, 2011
Days to Decision 24 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
105d faster than avg
Panel avg: 129d · This submission: 24d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code LJS Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5970
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - LJS Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days

All 180
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