Cleared Traditional

K851195 - VASCULAR ACCESS CATHETER

K851195 is the FDA 510(k) clearance for VASCULAR ACCESS CATHETER by Sil-Med Corp.. It is a Class 2 General Hospital device (product code LJS) cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K851195 · Sil-Med Corp. · General Hospital
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Jun 1985
Decision
73d
Days
Class 2
Risk

K851195 is an FDA 510(k) clearance for the VASCULAR ACCESS CATHETER. Classified as Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (product code LJS), Class II - Special Controls.

Submitted by Sil-Med Corp. (Taunton, US). The FDA issued a Cleared decision on June 7, 1985 after a review of 73 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Sil-Med Corp. devices

Submission Details

510(k) Number K851195 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 1985
Decision Date June 07, 1985
Days to Decision 73 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 129d · This submission: 73d
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 183
Devices cleared under the same product code (LJS) and FDA review panel - the closest regulatory comparables to K851195.
MULTILUMEN CENTRAL VENOUS CATH. W/VITACUFF DEVICE
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K844080 · Arrow Intl., Inc. · Apr 1985
ARGYLE SILICONE CENTRAL VENOUS CATH-
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SHEATH REMOVER
K841878 · Datascope Corp. · Jul 1984