Cleared Traditional

K953256 - STRATO/INFUSAID INFUS-A-CATH DUAL LUMEN PREATTACHED SILICONE CENTRAL VENOUS CATHETER SYSTEMS

K953256 is an FDA 510(k) clearance for STRATO/INFUSAID INFUS-A-CATH DUAL LUMEN..., manufactured by Strato/Infusaid, Inc.. The device is a Class 2 General Hospital device with product code LJS cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K953256 · Strato/Infusaid, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1995
Decision
84d
Days
Class 2
Risk

K953256 is an FDA 510(k) clearance for the STRATO/INFUSAID INFUS-A-CATH DUAL LUMEN PREATTACHED SILICONE CENTRAL VENOUS C.... Classified as Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (product code LJS), Class II - Special Controls.

Submitted by Strato/Infusaid, Inc. (Norwood, US). The FDA issued a Cleared decision on October 4, 1995 after a review of 84 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 Strato/Infusaid, Inc. devices

FDA 510(k) Submission Details - K953256

510(k) Number K953256 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 1995
Decision Date October 04, 1995
Days to Decision 84 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
45d faster than avg
Panel avg: 129d · This submission: 84d
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 257
Devices cleared under the same product code (LJS) and FDA review panel - the closest regulatory comparables to K953256.
PS MEDICAL IPI VASCULAR ACCESS CATHETER
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PER-Q-CATH MID-LINE
K954422 · Gesco Intl., Inc. · Dec 1995
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K954104 · C.R. Bard, Inc. · Nov 1995
CATHETER, INTRAVASCULAR OR PERCUTANEOUS
K951078 · Sims Deltec, Inc. · Jul 1995
STRATO MEDICAL INFUSE-A-CATH TRIPLE LUMEN SILICONE CATHETER SYSTEMS
K945956 · Strato Medical Corp. · Jun 1995
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K951098 · Hdc Corp. · Jun 1995