Cleared Traditional

K961461 - DANESHVAR'S DEVICE (MODIFICATION)

K961461 is an FDA 510(k) clearance for DANESHVAR'S DEVICE (MODIFICATION), 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 85-day FDA review.

K961461 · Y. Daneshvar · Cardiovascular device
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Jun 1996
Decision
85d
Days
Class 2
Risk

K961461 is an FDA 510(k) clearance for the DANESHVAR'S DEVICE (MODIFICATION). Classified as Clamp, Vascular (product code DXC), Class II - Special Controls.

Submitted by Y. Daneshvar (Livonia, US). The FDA issued a Cleared decision on June 26, 1996 after a review of 85 days - a notably fast clearance 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: 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 Y. Daneshvar devices

FDA 510(k) Submission Details - K961461

510(k) Number K961461 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 1996
Decision Date June 26, 1996
Days to Decision 85 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 125d · This submission: 85d
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 151
Devices cleared under the same product code (DXC) and FDA review panel - the closest regulatory comparables to K961461.
HEARTPORT ENDOAORTIC CLAMP
K962510 · Heartport, Inc. · Sep 1996
D. DEVICE II
K955742 · Yousef Daneshvar · Aug 1996
TAPE & BANDAGE, ADHESIVE
K955270 · Robert R. Stevens · Aug 1996
MICRO ANASTOMOSIS CLAMP
K961100 · R.S.P. Medical Management, Inc. · Jun 1996
HEARTPORT ENDOAORTIC CLAMP
K955132 · Heartport, Inc. · Jun 1996
FEMOSTOP, FEMOSTOP PUMP
K954669 · Radi Medical Systems AB · Oct 1995