Cleared Traditional

K992174 - PILLING WECK SURGICAL AORTIC SPOON-JAW CLAMP

K992174 is an FDA 510(k) clearance for PILLING WECK SURGICAL AORTIC SPOON-JAW ..., manufactured by Pilling Weck Surgical. The device is a Class 2 Cardiovascular device with product code DXC cleared through the Traditional 510(k) pathway after a 269-day FDA review.

K992174 · Pilling Weck Surgical · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2000
Decision
269d
Days
Class 2
Risk

K992174 is an FDA 510(k) clearance for the PILLING WECK SURGICAL AORTIC SPOON-JAW CLAMP. Classified as Clamp, Vascular (product code DXC), Class II - Special Controls.

Submitted by Pilling Weck Surgical (Fort Washington, US). The FDA issued a Cleared decision on March 23, 2000 after a review of 269 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 Pilling Weck Surgical devices

FDA 510(k) Submission Details - K992174

510(k) Number K992174 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 1999
Decision Date March 23, 2000
Days to Decision 269 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
144d slower than avg
Panel avg: 125d · This submission: 269d
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 108
Devices cleared under the same product code (DXC) and FDA review panel - the closest regulatory comparables to K992174.
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
AESCULAP VASCULAR INSTRUMENTS
K992053 · Aesculap, Inc. · Jan 2000
CORDIS ENDOVASCULAR TEMPORARY OCCLUSION BALLOON CATHETER
K984214 · Cordis Neurovascular, Inc. · Aug 1999
FLEXIBLE VASCULAR CLAMP, VERSION 2
K991589 · Allegiance Healthcare Corp. · May 1999