Cleared Traditional

K924677 - STRATO MEDICAL INFUSE-A-CATH POLYURE CE...

K924677 is the FDA 510(k) clearance for STRATO MEDICAL INFUSE-A-CATH POLYURE CE... by Strato Medical Corp.. It is a Class 2 General Hospital device (product code LJS) cleared through the Traditional 510(k) pathway after a 317-day FDA review.

K924677 · Strato Medical Corp. · General Hospital
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Jul 1993
Decision
317d
Days
Class 2
Risk

K924677 is an FDA 510(k) clearance for the STRATO MEDICAL INFUSE-A-CATH POLYURE CEN VEN CATH. Classified as Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (product code LJS), Class II - Special Controls.

Submitted by Strato Medical Corp. (Beverly, US). The FDA issued a Cleared decision on July 30, 1993 after a review of 317 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Strato Medical Corp. devices

Submission Details

510(k) Number K924677 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received September 16, 1992
Decision Date July 30, 1993
Days to Decision 317 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
188d slower than avg
Panel avg: 129d · This submission: 317d
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 186
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