Cleared Traditional

K935494 - DANESHVAR'S DEVICE

K935494 is an FDA 510(k) clearance for DANESHVAR'S DEVICE, manufactured by Y. Daneshvar. The device is a Class 2 Cardiovascular device with product code DXC cleared through the Traditional 510(k) pathway after a 372-day FDA review.

K935494 · Y. Daneshvar · Cardiovascular device
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Nov 1994
Decision
372d
Days
Class 2
Risk

K935494 is an FDA 510(k) clearance for the DANESHVAR'S DEVICE. Classified as Clamp, Vascular (product code DXC), Class II - Special Controls.

Submitted by Y. Daneshvar (Livonia, US). The FDA issued a Cleared decision on November 22, 1994 after a review of 372 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 devices

FDA 510(k) Submission Details - K935494

510(k) Number K935494 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 1993
Decision Date November 22, 1994
Days to Decision 372 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
247d slower than avg
Panel avg: 125d · This submission: 372d
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 152
Devices cleared under the same product code (DXC) and FDA review panel - the closest regulatory comparables to K935494.
FOGARTY-HYDRAGRIP SURGICAL CLAMPS
K951413 · Baxter Healthcare Corp · Aug 1995
FEMOSTOP II
K944259 · Radi Medical Systems AB · Jul 1995
ATRAUMAX SURGICAL CLAMP
K950492 · Applied Medical Resources · May 1995
FLO-RESTER DISPOSABLE VESSEL OCCLUDER
K942812 · Bio-Vascular, Inc. · Aug 1994
COMPRESSAR UNIVERSAL (TM) SYSTEM
K925809 · Instromedix, Inc. · Feb 1993
RMI EXTERNAL CORONARY ARTERY OCCLUDER
K920936 · Research Medical, Inc. · Dec 1992