Cleared Traditional

K130897 - MEDCOMP VASCU-PICC WITH VALVE

K130897 is the FDA 510(k) clearance for MEDCOMP VASCU-PICC WITH VALVE by Medcomp ( Medical Components). It is a Class 2 General Hospital device (product code LJS) cleared through the Traditional 510(k) pathway after a 204-day FDA review.

K130897 · Medcomp ( Medical Components) · General Hospital
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Oct 2013
Decision
204d
Days
Class 2
Risk

K130897 is an FDA 510(k) clearance for the MEDCOMP VASCU-PICC WITH VALVE. Classified as Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (product code LJS), Class II - Special Controls.

Submitted by Medcomp ( Medical Components) (Harleysville, US). The FDA issued a Cleared decision on October 22, 2013 after a review of 204 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5970 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Medcomp ( Medical Components) devices

Submission Details

510(k) Number K130897 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 2013
Decision Date October 22, 2013
Days to Decision 204 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
75d slower than avg
Panel avg: 129d · This submission: 204d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 106
Devices cleared under the same product code (LJS) and FDA review panel - the closest regulatory comparables to K130897.
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K132885 · Cook Incorporated · Oct 2013
TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC) SET
K132334 · Cook, Inc. · Aug 2013
THE SHERLOCK 3CG TIP CONFIRMATION SYSTEM (TCS)
K113808 · C.R. Bard, Inc. · Mar 2012