Cleared Traditional

K992424 - SELDIFLEX LONG-TERM CENTRAL VENOUS CATH...

K992424 is an FDA 510(k) clearance for SELDIFLEX LONG-TERM CENTRAL VENOUS CATH..., manufactured by Plastimed Laboratoire Pharmaceutique. The device is a Class 2 General Hospital device with product code LJS cleared through the Traditional 510(k) pathway after a 527-day FDA review.

K992424 · Plastimed Laboratoire Pharmaceutique · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2000
Decision
527d
Days
Class 2
Risk

K992424 is an FDA 510(k) clearance for the SELDIFLEX LONG-TERM CENTRAL VENOUS CATHETER(40CM & 60CM IN LENGTH), MODELS 63.... Classified as Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (product code LJS), Class II - Special Controls.

Submitted by Plastimed Laboratoire Pharmaceutique (Cedex, FR). The FDA issued a Cleared decision on December 29, 2000 after a review of 527 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Plastimed Laboratoire Pharmaceutique devices

FDA 510(k) Submission Details - K992424

510(k) Number K992424 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 1999
Decision Date December 29, 2000
Days to Decision 527 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
398d slower than avg
Panel avg: 129d · This submission: 527d
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 191
Devices cleared under the same product code (LJS) and FDA review panel - the closest regulatory comparables to K992424.
POLY PER-Q-CATH SINGLE LUMEN PICC CATHETER, MODEL 3143100
K012902 · C.R. Bard, Inc. · Sep 2001
CENTRAL VENOUS CATHETER
K003839 · Boston Scientific Corp · Aug 2001
MEDCOMP Z-CATH
K003682 · Medical Components, Inc. · Jan 2001
MEDCOMP BIO-CATH CATHETER LINE
K003110 · Medcomp · Dec 2000
PERIPHERALLY INSERTED CENTRAL CATHETER
K001874 · Utah Medical Products, Inc. · Sep 2000
POLY PER-Q-CATH PICC CATHETER,MODEL 3236100 AND POLY PER-Q-CATH MIDLINE CATHETER, MODEL 3134135
K001901 · C.R. Bard, Inc. · Sep 2000