Cleared Traditional

K932509 - STRATO MEDICAL INFUSE-A-PORT/SNAP-LOCK ...

K932509 is the FDA 510(k) clearance for STRATO MEDICAL INFUSE-A-PORT/SNAP-LOCK ... by Strato Medical Corp.. It is a Class 2 General Hospital device (product code LJT) cleared through the Traditional 510(k) pathway after a 227-day FDA review.

K932509 · Strato Medical Corp. · General Hospital
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Jan 1994
Decision
227d
Days
Class 2
Risk

K932509 is an FDA 510(k) clearance for the STRATO MEDICAL INFUSE-A-PORT/SNAP-LOCK MACROPRORT. 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 7, 1994 after a review of 227 days - an extended review cycle.

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: 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 Strato Medical Corp. devices

Submission Details

510(k) Number K932509 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 25, 1993
Decision Date January 07, 1994
Days to Decision 227 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
98d slower than avg
Panel avg: 129d · This submission: 227d
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

All 122
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PORT-A-CATH DUAL LUMEN IMPLANTABLE VENOUS ACCESS S
K932095 · Pharmacia Deltec, Inc. · Jan 1994
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K932840 · Pharmacia Deltec, Inc. · Jan 1994
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K932841 · Pharmacia Deltec, Inc. · Jan 1994