Cleared Traditional

K070661 - VITALCOR FEATHERWEIGHT VASCULAR CLAMPS

K070661 is an FDA 510(k) clearance for VITALCOR FEATHERWEIGHT VASCULAR CLAMPS, manufactured by Vitalcor, Inc.. The device is a Class 2 Cardiovascular device with product code DXC cleared through the Traditional 510(k) pathway after a 173-day FDA review.

K070661 · Vitalcor, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2007
Decision
173d
Days
Class 2
Risk

K070661 is an FDA 510(k) clearance for the VITALCOR FEATHERWEIGHT VASCULAR CLAMPS. Classified as Clamp, Vascular (product code DXC), Class II - Special Controls.

Submitted by Vitalcor, Inc. (Deer Field, US). The FDA issued a Cleared decision on August 29, 2007 after a review of 173 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.

FDA 510(k) Submission Details - K070661

510(k) Number K070661 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 2007
Decision Date August 29, 2007
Days to Decision 173 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
48d slower than avg
Panel avg: 125d · This submission: 173d
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 195
Devices cleared under the same product code (DXC) and FDA review panel - the closest regulatory comparables to K070661.
BOOMERANG CATALYST/BOOMERANG CATALYST II SYSTEM
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K072167 · Advanced Vascular Dynamics · Sep 2007
INNOVASA STAT*SEAL TOPICAL HEMOSTAT
K071225 · Innovasa, Inc. · Aug 2007
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
K070661 · VITALCOR FEATHERWEIGHT VASCULAR CLAMPS
Download PDF FDA Summary Vitalcor, Inc.