Cleared Traditional

PREMICATH, 1261.205 (K041468) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K041468 · Vygon Corp. · General Hospital
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Sep 2004
Decision
99d
Days
Class 2
Risk

K041468 is an FDA 510(k) clearance for the PREMICATH, 1261.205. Classified as Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (product code LJS), Class II - Special Controls.

Submitted by Vygon Corp. (Norristown, US). The FDA issued a Cleared decision on September 9, 2004 after a review of 99 days - within the typical 510(k) review window.

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 Vygon Corp. devices

Submission Details

510(k) Number K041468 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 2004
Decision Date September 09, 2004
Days to Decision 99 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 129d · This submission: 99d
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 90
Devices cleared under the same product code (LJS) and FDA review panel - the closest regulatory comparables to K041468.
6 FR POLY PER-Q-CATH TRIPLE LUMEN PICC
K043502 · C.R. Bard, Inc. · Jan 2005
BD ONECATH PERIPHERALLY INSERTED CENTRAL CATHETER
K042491 · Becton, Dickinson & CO · Nov 2004
TRIFUSION, MODEL 0609190/0659350
K041088 · C.R. Bard, Inc. · Nov 2004
POWERPICC CATHETERS, MODELS 3175155, 3175135
K033389 · C.R. Bard, Inc. · Mar 2004
POLY PER-Q-CATH PICC CATHETERS
K034019 · C.R. Bard, Inc. · Jan 2004
GROSHONG NXT PICC CATHETERS
K034020 · C.R. Bard, Inc. · Jan 2004