Cleared Traditional

K934518 - STRATO MEDICAL INFUSE-A-PORT/INFUSE-A-K...

K934518 is the FDA 510(k) clearance for STRATO MEDICAL INFUSE-A-PORT/INFUSE-A-K... by Strato Medical Corp.. It is a Class 2 General Hospital device (product code LJT) cleared through the Traditional 510(k) pathway after a 497-day FDA review.

K934518 · Strato Medical Corp. · General Hospital
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Optimized for regulatory review, auditing and printing
Jan 1995
Decision
497d
Days
Class 2
Risk

K934518 is an FDA 510(k) clearance for the STRATO MEDICAL INFUSE-A-PORT/INFUSE-A-KIT PERIPORT PERIPHERAL ACCESS SYSTEM. Classified as Port & Catheter, Implanted, Subcutaneous, Intravascular (product code LJT), Class II - Special Controls.

Submitted by Strato Medical Corp. (Beverly, US). The FDA issued a Cleared decision on January 27, 1995 after a review of 497 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5965 - 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 Strato Medical Corp. devices

Submission Details

510(k) Number K934518 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received September 17, 1993
Decision Date January 27, 1995
Days to Decision 497 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
368d slower than avg
Panel avg: 129d · This submission: 497d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5965
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 - LJT Port & Catheter, Implanted, Subcutaneous, Intravascular

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