Cleared Traditional

K003839 - CENTRAL VENOUS CATHETER

K003839 is an FDA 510(k) clearance for CENTRAL VENOUS CATHETER, manufactured by Boston Scientific Corp. The device is a Class 2 General Hospital device with product code LJS cleared through the Traditional 510(k) pathway after a 232-day FDA review.

K003839 · Boston Scientific Corp · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2001
Decision
232d
Days
Class 2
Risk

K003839 is an FDA 510(k) clearance for the CENTRAL VENOUS CATHETER. Classified as Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (product code LJS), Class II - Special Controls.

Submitted by Boston Scientific Corp (Natick,, US). The FDA issued a Cleared decision on August 1, 2001 after a review of 232 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 Boston Scientific Corp devices

FDA 510(k) Submission Details - K003839

510(k) Number K003839 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 2000
Decision Date August 01, 2001
Days to Decision 232 days
Submission Type Traditional
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
103d slower than avg
Panel avg: 129d · This submission: 232d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LJS Device Classification - Class 2, Special Controls

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 256
Devices cleared under the same product code (LJS) and FDA review panel - the closest regulatory comparables to K003839.
SILICONE DUAL LUMEN RADPICC CATHETERS
K030255 · C.R. Bard, Inc. · Feb 2003
GROSHONG NXT DUAL LUMEN PICC CATHETERS
K023374 · C.R. Bard, Inc. · Dec 2002
POLY PER-Q-CATH SINGLE LUMEN PICC CATHETER, MODEL 3143100
K012902 · C.R. Bard, Inc. · Sep 2001
MEDCOMP Z-CATH
K003682 · Medical Components, Inc. · Jan 2001
SELDIFLEX LONG-TERM CENTRAL VENOUS CATHETER(40CM & 60CM IN LENGTH), MODELS 63244J20 & 63246J20
K992424 · Plastimed Laboratoire Pharmaceutique · Dec 2000
MEDCOMP BIO-CATH CATHETER LINE
K003110 · Medcomp · Dec 2000