Cleared Abbreviated

K130714 - PROGIGY SUPPORT CATHETER

K130714 is an FDA 510(k) clearance for PROGIGY SUPPORT CATHETER, manufactured by Radius Medical, LLC. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Abbreviated 510(k) pathway after a 160-day FDA review.

K130714 · Radius Medical, LLC · Cardiovascular device
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Aug 2013
Decision
160d
Days
Class 2
Risk

K130714 is an FDA 510(k) clearance for the PROGIGY SUPPORT CATHETER. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Radius Medical, LLC (Hudson, US). The FDA issued a Cleared decision on August 22, 2013 after a review of 160 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - the FDA cardiovascular device oversight 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 Radius Medical, LLC devices

FDA 510(k) Submission Details - K130714

510(k) Number K130714 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 2013
Decision Date August 22, 2013
Days to Decision 160 days
Submission Type Abbreviated
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d slower than avg
Panel avg: 125d · This submission: 160d
Pathway characteristics
Standards-based clearance path.

DQY Device Classification - Class 2, Special Controls

Product Code DQY Catheter, Percutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
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 - DQY Catheter, Percutaneous

All 655
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