Cleared Traditional

K042062 - PERIPHERAL VASCULAR SHEATH TUNNELER STE...

K042062 is the FDA 510(k) clearance for PERIPHERAL VASCULAR SHEATH TUNNELER STE... by Bard Peripheral Vascular, Inc.. It is a Class 2 General Hospital device (product code KCT) cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K042062 · Bard Peripheral Vascular, Inc. · General Hospital
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Sep 2004
Decision
59d
Days
Class 2
Risk

K042062 is an FDA 510(k) clearance for the PERIPHERAL VASCULAR SHEATH TUNNELER STERILIZATION CASSETTE. Classified as Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (product code KCT), Class II - Special Controls.

Submitted by Bard Peripheral Vascular, Inc. (Tempe, US). The FDA issued a Cleared decision on September 30, 2004 after a review of 59 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6850 - 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 Bard Peripheral Vascular, Inc. devices

Submission Details

510(k) Number K042062 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 2004
Decision Date September 30, 2004
Days to Decision 59 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 129d · This submission: 59d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

Product Code KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6850
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.

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All 162
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