Cleared Traditional

K063871 - D-STAT HANDLE, MODEL 8500-053

K063871 is an FDA 510(k) clearance for D-STAT HANDLE, manufactured by Vascular Solutions, Inc.. The device is a Class 2 Cardiovascular device with product code DXC cleared through the Traditional 510(k) pathway after a 61-day FDA review.

K063871 · Vascular Solutions, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2007
Decision
61d
Days
Class 2
Risk

K063871 is an FDA 510(k) clearance for the D-STAT HANDLE, MODEL 8500-053. Classified as Clamp, Vascular (product code DXC), Class II - Special Controls.

Submitted by Vascular Solutions, Inc. (Minneapolis, US). The FDA issued a Cleared decision on February 28, 2007 after a review of 61 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.

FDA 510(k) Submission Details - K063871

510(k) Number K063871 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 2006
Decision Date February 28, 2007
Days to Decision 61 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 125d · This submission: 61d
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 202
Devices cleared under the same product code (DXC) and FDA review panel - the closest regulatory comparables to K063871.
PORTACLAMP FLEX
K070380 · Cardio Life Research, S.A. · Jun 2007
TR BAND
K070423 · Terumo Medical Corp. · Mar 2007
BOOMERANG WIRE /BOOMERANG PLUS WIRE SYSTEM, MODEL# B PLUS WIRE 58L
K070485 · Cardiva Medical, Inc. · Mar 2007
TEMPORARY LIMB SALVAGE SHUNT
K070323 · Vascutek, Ltd. · Feb 2007
SAFEGUARD 24 CM PRESSURE ASSISTED DRESSING
K062569 · Datascope Corp. · Feb 2007
MODIFICATION TO: SMITHWICK CAROTID SHUNT
K061484 · Mcpherson Enterprises, Inc. · Dec 2006
K063871 · D-STAT HANDLE, MODEL 8500-053
Download PDF FDA Summary Vascular Solutions, I…