Cleared Abbreviated

K071202 - DERMAPORT PERCUTANEOUS VASCULAR ACCESS ...

K071202 is an FDA 510(k) clearance for DERMAPORT PERCUTANEOUS VASCULAR ACCESS ..., manufactured by Dermaport, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code MSD cleared through the Abbreviated 510(k) pathway after a 213-day FDA review.

K071202 · Dermaport, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2007
Decision
213d
Days
Class 2
Risk

K071202 is an FDA 510(k) clearance for the DERMAPORT PERCUTANEOUS VASCULAR ACCESS SYSTEM (PVAS). Classified as Catheter, Hemodialysis, Implanted (product code MSD), Class II - Special Controls.

Submitted by Dermaport, Inc. (Stoughton, US). The FDA issued a Cleared decision on November 30, 2007 after a review of 213 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5540 - the FDA gastroenterology and urology device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Dermaport, Inc. devices

FDA 510(k) Submission Details - K071202

510(k) Number K071202 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received May 01, 2007
Decision Date November 30, 2007
Days to Decision 213 days
Submission Type Abbreviated
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
83d slower than avg
Panel avg: 130d · This submission: 213d
Pathway characteristics
Standards-based clearance path.

MSD Device Classification - Class 2, Special Controls

Product Code MSD Catheter, Hemodialysis, Implanted
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5540
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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - MSD Catheter, Hemodialysis, Implanted

All 64
Devices cleared under the same product code (MSD) and FDA review panel - the closest regulatory comparables to K071202.
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K051280 · Medcomp · Nov 2005
HEMOGLIDE SERIES AND HEMOGLIDE STAR SERIES XK LONG-TERM HEMODIALYSIS CATHETERS
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MEDCOMP SPLIT-CATH II
K040318 · Medcomp · Feb 2005