Cleared Traditional

K924677 - STRATO MEDICAL INFUSE-A-CATH POLYURE CEN VEN CATH

K924677 is an FDA 510(k) clearance for STRATO MEDICAL INFUSE-A-CATH POLYURE CE..., manufactured by Strato Medical Corp.. The device is a Class 2 General Hospital device with 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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Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K924677

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.

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 263
Devices cleared under the same product code (LJS) and FDA review panel - the closest regulatory comparables to K924677.
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