Cleared Special

K991898 - ULTRA-SELECT GUIDEWIRE, HYTEK GUIDEWIRE

K991898 is an FDA 510(k) clearance for ULTRA-SELECT GUIDEWIRE, manufactured by Microvena Corp.. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Special 510(k) pathway after a 12-day FDA review.

K991898 · Microvena Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1999
Decision
12d
Days
Class 2
Risk

K991898 is an FDA 510(k) clearance for the ULTRA-SELECT GUIDEWIRE, HYTEK GUIDEWIRE. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Microvena Corp. (White Bear Lake, US). The FDA issued a Cleared decision on June 16, 1999 after a review of 12 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Microvena Corp. devices

FDA 510(k) Submission Details - K991898

510(k) Number K991898 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 1999
Decision Date June 16, 1999
Days to Decision 12 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
113d faster than avg
Panel avg: 125d · This submission: 12d
Pathway characteristics
Modification to existing cleared device.

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 617
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K991898.
.010 SILVERSPEED HYDROPOPHILIC GUIDEWIRE, .014 SILVERSPED HYDROPHILIC GUIDEWIRE, .016 SILVERSPEED HYDROPHILIC GUIDEWI
K993257 · Micro Therapeutics, Inc. · Oct 1999
AGILITY STEERABLE GUIDEWIRE
K991646 · Cordis Neurovascular, Inc. · Sep 1999
MEDTRONIC GT2 FUSION GUIDE WIRES
K992237 · Medtronic Vascular · Sep 1999
MODIFICATION TO ULTRA-SELECT GUIDEWIRE
K991194 · Microvena Corp. · May 1999
HI-TORQUE BALANCE TREK GUIDE WIRE
K991152 · Guidant Corp. · Apr 1999
ACS HI-TORQUE CROSS IT 100XT, 200XT AND 300XT GUIDE WIRES WITH HYDROCOAT HYDROPHILIC COATING.
K990639 · Guidant Corp. · Mar 1999