Cleared Traditional

K910564 - VERSACATH(TM0 MAINLINE(TM) WITH INTRODU...

K910564 is the FDA 510(k) clearance for VERSACATH(TM0 MAINLINE(TM) WITH INTRODU... by Menlo Care, Inc.. It is a Class 2 General Hospital device (product code FOZ) cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K910564 · Menlo Care, Inc. · General Hospital
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May 1991
Decision
87d
Days
Class 2
Risk

K910564 is an FDA 510(k) clearance for the VERSACATH(TM0 MAINLINE(TM) WITH INTRODUCTION TRAY. Classified as Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (product code FOZ), Class II - Special Controls.

Submitted by Menlo Care, Inc. (Menlo Park, US). The FDA issued a Cleared decision on May 6, 1991 after a review of 87 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5200 - 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 Menlo Care, Inc. devices

Submission Details

510(k) Number K910564 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 1991
Decision Date May 06, 1991
Days to Decision 87 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
42d faster than avg
Panel avg: 129d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FOZ Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5200
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 - FOZ Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days

All 265
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