Cleared Traditional

K060643 - QL LOCKING SYRINGE

K060643 is an FDA 510(k) clearance for QL LOCKING SYRINGE, manufactured by Atrion Medical Products, Inc.. The device is a Class 2 Cardiovascular device with product code MAV cleared through the Traditional 510(k) pathway after a 124-day FDA review.

K060643 · Atrion Medical Products, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2006
Decision
124d
Days
Class 2
Risk

K060643 is an FDA 510(k) clearance for the QL LOCKING SYRINGE. Classified as Syringe, Balloon Inflation (product code MAV), Class II - Special Controls.

Submitted by Atrion Medical Products, Inc. (Arab, US). The FDA issued a Cleared decision on July 12, 2006 after a review of 124 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1650 - 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 Atrion Medical Products, Inc. devices

FDA 510(k) Submission Details - K060643

510(k) Number K060643 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 2006
Decision Date July 12, 2006
Days to Decision 124 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
1d faster than avg
Panel avg: 125d · This submission: 124d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MAV Device Classification - Class 2, Special Controls

Product Code MAV Syringe, Balloon Inflation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1650
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 - MAV Syringe, Balloon Inflation

All 39
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