Cleared Traditional

K071225 - INNOVASA STAT*SEAL TOPICAL HEMOSTAT

K071225 is an FDA 510(k) clearance for INNOVASA STAT*SEAL TOPICAL HEMOSTAT, manufactured by Innovasa, Inc.. The device is a Class 2 Cardiovascular device with product code DXC cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K071225 · Innovasa, Inc. · Cardiovascular device
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Aug 2007
Decision
121d
Days
Class 2
Risk

K071225 is an FDA 510(k) clearance for the INNOVASA STAT*SEAL TOPICAL HEMOSTAT. Classified as Clamp, Vascular (product code DXC), Class II - Special Controls.

Submitted by Innovasa, Inc. (Redmond, US). The FDA issued a Cleared decision on August 31, 2007 after a review of 121 days - within the typical 510(k) review window.

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 - K071225

510(k) Number K071225 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 2007
Decision Date August 31, 2007
Days to Decision 121 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
4d faster than avg
Panel avg: 125d · This submission: 121d
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 K071225.
SIBEL SA VASCULAR CLAMP
K072834 · Surgical Instruments Belgium SA · Jan 2008
BOOMERANG CATALYST/BOOMERANG CATALYST II SYSTEM
K072297 · Cardiva Medical, Inc. · Sep 2007
COMFORTPRESS VASCULAR COMPRESSION ASSIST DEVICE
K072167 · Advanced Vascular Dynamics · Sep 2007
VITALCOR FEATHERWEIGHT VASCULAR CLAMPS
K070661 · Vitalcor, Inc. · Aug 2007
PORTACLAMP FLEX
K070380 · Cardio Life Research, S.A. · Jun 2007
TR BAND
K070423 · Terumo Medical Corp. · Mar 2007
K071225 · INNOVASA STAT*SEAL TOPICAL HEMOSTAT
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