Cleared Traditional

K062868 - THE CROSSER CATHETER, MODEL CR1100 AND SYSTEM ELECTRONICS, MODEL FG1002-02

K062868 is an FDA 510(k) clearance for THE CROSSER CATHETER, manufactured by Flowcardia, Inc.. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Traditional 510(k) pathway after a 116-day FDA review.

K062868 · Flowcardia, Inc. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Jan 2007
Decision
116d
Days
Class 2
Risk

K062868 is an FDA 510(k) clearance for the THE CROSSER CATHETER, MODEL CR1100 AND SYSTEM ELECTRONICS, MODEL FG1002-02. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Flowcardia, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on January 19, 2007 after a review of 116 days - within the typical 510(k) review window.

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 Flowcardia, Inc. devices

FDA 510(k) Submission Details - K062868

510(k) Number K062868 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 2006
Decision Date January 19, 2007
Days to Decision 116 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
9d faster than avg
Panel avg: 125d · This submission: 116d
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 669
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K062868.
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