Cleared Traditional

K943948 - PROTECTIVE SHORTS

K943948 is an FDA 510(k) clearance for PROTECTIVE SHORTS, manufactured by Y. Daneshvar, M.D.. The device is a Class 2 Cardiovascular device with product code DXC cleared through the Traditional 510(k) pathway after a 291-day FDA review.

K943948 · Y. Daneshvar, M.D. · Cardiovascular device
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Jun 1995
Decision
291d
Days
Class 2
Risk

K943948 is an FDA 510(k) clearance for the PROTECTIVE SHORTS. Classified as Clamp, Vascular (product code DXC), Class II - Special Controls.

Submitted by Y. Daneshvar, M.D. (Livonia, US). The FDA issued a Cleared decision on June 5, 1995 after a review of 291 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4450 - the FDA cardiovascular device oversight 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 Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Y. Daneshvar, M.D. devices

FDA 510(k) Submission Details - K943948

510(k) Number K943948 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 1994
Decision Date June 05, 1995
Days to Decision 291 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
166d slower than avg
Panel avg: 125d · This submission: 291d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXC Device Classification - Class 2, Special Controls

Product Code DXC Clamp, Vascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4450
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - DXC Clamp, Vascular

All 172
Devices cleared under the same product code (DXC) and FDA review panel - the closest regulatory comparables to K943948.
FEMOSTOP, FEMOSTOP PUMP
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ATRAUMAX SURGICAL CLAMP
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K942812 · Bio-Vascular, Inc. · Aug 1994
COMPRESSAR UNIVERSAL (TM) SYSTEM
K925809 · Instromedix, Inc. · Feb 1993