Cleared Traditional

K093822 - DOCKING STATION,TEIRSTEIN EDGE,ANGIOASSIST COMBINATION DEVICE, ANGIOASSIST FAMILY

K093822 is an FDA 510(k) clearance for DOCKING STATION, manufactured by Shepherd Scientific, Inc.. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K093822 · Shepherd Scientific, Inc. · Cardiovascular device
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Jan 2010
Decision
45d
Days
Class 2
Risk

K093822 is an FDA 510(k) clearance for the DOCKING STATION,TEIRSTEIN EDGE,ANGIOASSIST COMBINATION DEVICE, ANGIOASSIST FA.... Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Shepherd Scientific, Inc. (La Jolla, US). The FDA issued a Cleared decision on January 28, 2010 after a review of 45 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1330 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Shepherd Scientific, Inc. devices

FDA 510(k) Submission Details - K093822

510(k) Number K093822 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 2009
Decision Date January 28, 2010
Days to Decision 45 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
80d faster than avg
Panel avg: 125d · This submission: 45d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

DQX Device Classification - Class 2, Special Controls

Product Code DQX Wire, Guide, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1330
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 - DQX Wire, Guide, Catheter

All 625
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K093822.
NEUROSCOUT STEERABLE GUIDEWIRE
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GTX GUIDEWIRE, MODELS TBD-GTX 1, 3,6,9,12, 15
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