Cleared Traditional

K060927 - CERES PTA CATHETER MODELS PTA018,PTA035 VARIOUS SIZES

K060927 is an FDA 510(k) clearance for CERES PTA CATHETER MODELS PTA018, manufactured by Ceres Medical Systems, LLC. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Traditional 510(k) pathway after a 185-day FDA review.

K060927 · Ceres Medical Systems, LLC · Cardiovascular device
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Oct 2006
Decision
185d
Days
Class 2
Risk

K060927 is an FDA 510(k) clearance for the CERES PTA CATHETER MODELS PTA018,PTA035 VARIOUS SIZES. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Ceres Medical Systems, LLC (San Diego, US). The FDA issued a Cleared decision on October 6, 2006 after a review of 185 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 Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Ceres Medical Systems, LLC devices

FDA 510(k) Submission Details - K060927

510(k) Number K060927 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 2006
Decision Date October 06, 2006
Days to Decision 185 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d slower than avg
Panel avg: 125d · This submission: 185d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 688
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