Cleared Traditional

K992053 - AESCULAP VASCULAR INSTRUMENTS

K992053 is the FDA 510(k) clearance for AESCULAP VASCULAR INSTRUMENTS by Aesculap, Inc.. It is a Class 2 Cardiovascular device (product code DXC) cleared through the Traditional 510(k) pathway after a 209-day FDA review.

K992053 · Aesculap, Inc. · Cardiovascular device
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Jan 2000
Decision
209d
Days
Class 2
Risk

K992053 is an FDA 510(k) clearance for the AESCULAP VASCULAR INSTRUMENTS. Classified as Clamp, Vascular (product code DXC), Class II - Special Controls.

Submitted by Aesculap, Inc. (South San Francisco, US). The FDA issued a Cleared decision on January 13, 2000 after a review of 209 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.

View all Aesculap, Inc. devices

Submission Details

510(k) Number K992053 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 1999
Decision Date January 13, 2000
Days to Decision 209 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
84d slower than avg
Panel avg: 125d · This submission: 209d
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 K992053.
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
CORDIS ENDOVASCULAR TEMPORARY OCCLUSION BALLOON CATHETER
K984214 · Cordis Neurovascular, Inc. · Aug 1999
FLEXIBLE VASCULAR CLAMP, VERSION 2
K991589 · Allegiance Healthcare Corp. · May 1999
COSGROVE CLAMP
K974769 · Allegiance Healthcare Corp. · Jun 1998