Cleared Traditional

Sterile High-pressure Angiographic Syringes for Single-use (K151960) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K151960 · Shenzhen Baoan Medical Supplies Co., Ltd. · Cardiovascular device
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Jan 2016
Decision
175d
Days
Class 2
Risk

K151960 is an FDA 510(k) clearance for the Sterile High-pressure Angiographic Syringes for Single-use. Classified as Injector And Syringe, Angiographic (product code DXT), Class II - Special Controls.

Submitted by Shenzhen Baoan Medical Supplies Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on January 7, 2016 after a review of 175 days - an extended review cycle.

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 Shenzhen Baoan Medical Supplies Co., Ltd. devices

Submission Details

510(k) Number K151960 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 2015
Decision Date January 07, 2016
Days to Decision 175 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
50d slower than avg
Panel avg: 125d · This submission: 175d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DXT Injector And Syringe, Angiographic
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 - DXT Injector And Syringe, Angiographic

All 209
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