Cleared Special

K133587 - PRESSUREWIRE AERIS AGILE TIP

Also marketed or referenced as:
PRESSUREWIRE AERIS AGILE TIP 300

K133587 is an FDA 510(k) clearance for PRESSUREWIRE AERIS AGILE TIP, manufactured by St. Jude Medical Systems AB. The device is a Class 2 Cardiovascular device with product code DRG cleared through the Special 510(k) pathway after a 29-day FDA review.

K133587 · St. Jude Medical Systems AB · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2013
Decision
29d
Days
Class 2
Risk

K133587 is an FDA 510(k) clearance for the PRESSUREWIRE AERIS AGILE TIP. Classified as Transmitters And Receivers, Physiological Signal, Radiofrequency (product code DRG), Class II - Special Controls.

Submitted by St. Jude Medical Systems AB (Westford, US). The FDA issued a Cleared decision on December 20, 2013 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2910 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all St. Jude Medical Systems AB devices

FDA 510(k) Submission Details - K133587

510(k) Number K133587 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 2013
Decision Date December 20, 2013
Days to Decision 29 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
96d faster than avg
Panel avg: 125d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

DRG Device Classification - Class 2, Special Controls

Product Code DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2910
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 - DRG Transmitters And Receivers, Physiological Signal, Radiofrequency

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