Cleared Traditional

K911355 - LIFEPORT VASCU ACCESS SYST/PORT INTRO K...

K911355 is the FDA 510(k) clearance for LIFEPORT VASCU ACCESS SYST/PORT INTRO 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 53-day FDA review.

K911355 · Strato Medical Corp. · General Hospital
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Apr 1991
Decision
53d
Days
Class 2
Risk

K911355 is an FDA 510(k) clearance for the LIFEPORT VASCU ACCESS SYST/PORT INTRO KIT 7015. 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 April 15, 1991 after a review of 53 days - a notably fast clearance 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: 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 Medical Corp. devices

Submission Details

510(k) Number K911355 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 1991
Decision Date April 15, 1991
Days to Decision 53 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
76d faster than avg
Panel avg: 129d · This submission: 53d
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
Devices cleared under the same product code (LJT) and FDA review panel - the closest regulatory comparables to K911355.
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K905850 · Strato Medical Corp. · Apr 1991
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K905852 · Strato Medical Corp. · Apr 1991
STRATO LOW PROFILE PORT(LPS 1055)/MODIFICATION
K905846 · Strato Medical Corp. · Apr 1991
LIFE PT VASC ACCESS PT W/DETACH CATH(LPS 6013)MODI
K905848 · Strato Medical Corp. · Apr 1991
STRATO LIFE PORT II DUAL LUMEN PORT/MODIFICATION
K905847 · Strato Medical Corp. · Apr 1991