Cleared Traditional

K014277 - KSEA DEPLOYABLE CARDIOVASCULAR CLAMP

K014277 is the FDA 510(k) clearance for KSEA DEPLOYABLE CARDIOVASCULAR CLAMP by KARL STORZ Endoscopy-America, Inc.. It is a Class 2 Cardiovascular device (product code DXC) cleared through the Traditional 510(k) pathway after a 349-day FDA review.

K014277 · KARL STORZ Endoscopy-America, Inc. · Cardiovascular device
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Dec 2002
Decision
349d
Days
Class 2
Risk

K014277 is an FDA 510(k) clearance for the KSEA DEPLOYABLE CARDIOVASCULAR CLAMP. Classified as Clamp, Vascular (product code DXC), Class II - Special Controls.

Submitted by KARL STORZ Endoscopy-America, Inc. (Culver City, US). The FDA issued a Cleared decision on December 11, 2002 after a review of 349 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 KARL STORZ Endoscopy-America, Inc. devices

Submission Details

510(k) Number K014277 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 2001
Decision Date December 11, 2002
Days to Decision 349 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
224d slower than avg
Panel avg: 125d · This submission: 349d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 61
Devices cleared under the same product code (DXC) and FDA review panel - the closest regulatory comparables to K014277.
SAFEGUARD 24 CM PRESSURE ASSISTED DRESSING
K062569 · Datascope Corp. · Feb 2007
VASCULAR SOLUTIONS D-STAT CLAMP ACCESSORY
K050146 · Vascular Solutions, Inc. · May 2005
VASCULAR SOLUTIONS D-STAT CLAMP HEMOSTATIC CLAMP
K040730 · Vascular Solutions, Inc. · Jun 2004
GUIDANT PROXIMAL SEAL SYSTEM, MODELS PSS-4500 & PS-4500
K022880 · Guidant Corp. · Sep 2002
KSEA DION-GRACIA SET
K010785 · KARL STORZ Endoscopy-America, Inc. · Aug 2001
MALLEABLE SHAFT CLAMP
K011078 · Allegiance Healthcare Corp. · Jul 2001