Cleared Traditional

K834091 - SILCATH

K834091 is an FDA 510(k) clearance for SILCATH, manufactured by Hdc Corp.. The device is a Class 2 General Hospital device with product code LJS cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K834091 · Hdc Corp. · General Hospital
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Mar 1984
Decision
99d
Days
Class 2
Risk

K834091 is an FDA 510(k) clearance for the SILCATH. Classified as Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (product code LJS), Class II - Special Controls.

Submitted by Hdc Corp. (Walker, US). The FDA issued a Cleared decision on March 6, 1984 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 Hdc Corp. devices

FDA 510(k) Submission Details - K834091

510(k) Number K834091 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 28, 1983
Decision Date March 06, 1984
Days to Decision 99 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
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.

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 193
Devices cleared under the same product code (LJS) and FDA review panel - the closest regulatory comparables to K834091.
MULTI-LUMEN CENTRAL VENOUS CATH. KIT
K834473 · Burron Medical Products, Inc. · Apr 1984
DESERET LONG TERM INDWELLING CATHETER
K840958 · Parke-Davis Co. · Apr 1984
PEDIATRIC RIGHT ATRIAL CATHETER 1/3MM
K833442 · Quinton, Inc. · Mar 1984
RAAF DUAL LUMEN CATH. REPAIR KIT 2.2
K834225 · Quinton, Inc. · Feb 1984
RAAF CATHETER REPAIR KIT
K832580 · Quinton, Inc. · Jan 1984
REPAIR KITS FOR RIGHT ATRIAL CATH
K832774 · Quinton, Inc. · Jan 1984