Cleared Special

K103250 - CPS DIRECT SL II SLITTABLE OUTER CATHETER

K103250 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 77-day FDA review.

K103250 · St. Jude Medical, Cardiac Rhythm Management Divisi · Cardiovascular device
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Jan 2011
Decision
77d
Days
Class 2
Risk

K103250 is an FDA 510(k) clearance for the CPS DIRECT SL II SLITTABLE OUTER CATHETER. 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 January 19, 2011 after a review of 77 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.

FDA 510(k) Submission Details - K103250

510(k) Number K103250 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 2010
Decision Date January 19, 2011
Days to Decision 77 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 125d · This submission: 77d
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 861
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K103250.
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K103250 · CPS DIRECT SL II SLITTABLE OUTER CATHETER
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