Cleared Traditional

K100184 - FUSTAR STEERABLE INTRODUCERS

K100184 is an FDA 510(k) clearance for FUSTAR STEERABLE INTRODUCERS, manufactured by Lifetech Scientific (Shenzhen) Co., Ltd.. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Traditional 510(k) pathway after a 389-day FDA review.

K100184 · Lifetech Scientific (Shenzhen) Co., Ltd. · Cardiovascular device
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Feb 2011
Decision
389d
Days
Class 2
Risk

K100184 is an FDA 510(k) clearance for the FUSTAR STEERABLE INTRODUCERS. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Lifetech Scientific (Shenzhen) Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on February 14, 2011 after a review of 389 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Lifetech Scientific (Shenzhen) Co., Ltd. devices

FDA 510(k) Submission Details - K100184

510(k) Number K100184 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 2010
Decision Date February 14, 2011
Days to Decision 389 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
264d slower than avg
Panel avg: 125d · This submission: 389d
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 600
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K100184.
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SUPERCROSS MICROCATHETER (130 CM), SUPERCROSS MICROCATHETER (150 CM) MODEL 5300, 5301
K101659 · Vascular Solutions, Inc. · Dec 2010
SEEKER CROSSING SUPPORT CATHETER
K103367 · Bard Peripheral Vascular, Inc. · Dec 2010