Cleared Traditional

K011373 - INSTRUMENT DAMPING PORT

K011373 is an FDA 510(k) clearance for INSTRUMENT DAMPING PORT, manufactured by Medcanica, Inc.. The device is a Class 2 Cardiovascular device with product code DRC cleared through the Traditional 510(k) pathway after a 161-day FDA review.

K011373 · Medcanica, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2001
Decision
161d
Days
Class 2
Risk

K011373 is an FDA 510(k) clearance for the INSTRUMENT DAMPING PORT. Classified as Trocar (product code DRC), Class II - Special Controls.

Submitted by Medcanica, Inc. (Miami, US). The FDA issued a Cleared decision on October 12, 2001 after a review of 161 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1390 - 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 Medcanica, Inc. devices

FDA 510(k) Submission Details - K011373

510(k) Number K011373 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 2001
Decision Date October 12, 2001
Days to Decision 161 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
36d slower than avg
Panel avg: 125d · This submission: 161d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRC Device Classification - Class 2, Special Controls

Product Code DRC Trocar
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1390
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 - DRC Trocar

All 36
Devices cleared under the same product code (DRC) and FDA review panel - the closest regulatory comparables to K011373.
BRK TRANSSEPTAL NEEDLE
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MAJESTIK (TM) SHIELDED ANGIOGRAPHY NEEDLE, MODEL STAN18T71W-25, MAJESTIK (TM) SHIELDED ANGIOGTAPHY NEEDLE, SRAN18T71WR-5
K022117 · Merit Medical Systems, Inc. · Oct 2002
TRANSSEPTAL NEEDLE/TROCAR
K011727 · Thomas Medical Products, Inc. · May 2002
MANAN POTTS-COURNAND NEEDLE
K974742 · Medical Device Technologies, Inc. · Apr 1998
MANAN
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MANAN GWI GUIDE WIRE INTRODUCER
K974745 · Medical Device Technologies, Inc. · Apr 1998