Cleared Special

K092075 - CPS DIRECT SL II SLITTABLE OUTER CATHETER, MODELS DS2C001, DS2C002, DS2C003, DS2C004, DS2C005

K092075 is an FDA 510(k) clearance for CPS DIRECT SL II SLITTABLE OUTER CATHETER, manufactured by St. Jude Medical, Cardiac Rhythm Management Divisi. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Special 510(k) pathway after a 29-day FDA review.

K092075 · St. Jude Medical, Cardiac Rhythm Management Divisi · Cardiovascular device
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Aug 2009
Decision
29d
Days
Class 2
Risk

K092075 is an FDA 510(k) clearance for the CPS DIRECT SL II SLITTABLE OUTER CATHETER, MODELS DS2C001, DS2C002, DS2C003, .... Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by St. Jude Medical, Cardiac Rhythm Management Divisi (Sylmar, US). The FDA issued a Cleared decision on August 7, 2009 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - 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, Cardiac Rhythm Management Divisi devices

FDA 510(k) Submission Details - K092075

510(k) Number K092075 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 2009
Decision Date August 07, 2009
Days to Decision 29 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Statement
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.

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 659
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