Cleared Traditional

K914828 - 010 HI-TOR INTER/STAND GUIDWIRE PRESHAP...

K914828 is the FDA 510(k) clearance for 010 HI-TOR INTER/STAND GUIDWIRE PRESHAP... by Advanced Cardiovascular Systems, Inc.. It is a Class 2 Cardiovascular device (product code DQX) cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K914828 · Advanced Cardiovascular Systems, Inc. · Cardiovascular device
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Jan 1992
Decision
76d
Days
Class 2
Risk

K914828 is an FDA 510(k) clearance for the 010 HI-TOR INTER/STAND GUIDWIRE PRESHAPE TIP/MODIF. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Advanced Cardiovascular Systems, Inc. (Santa Clara, US). The FDA issued a Cleared decision on January 8, 1992 after a review of 76 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 Advanced Cardiovascular Systems, Inc. devices

Submission Details

510(k) Number K914828 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 24, 1991
Decision Date January 08, 1992
Days to Decision 76 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 125d · This submission: 76d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 501
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K914828.
GUIDER-22
K914031 · Target Therapeutics · Feb 1992
NITINOL SEEKER(R) GUIDE WIRES
K914032 · Target Therapeutics · Feb 1992
GUIDE WIRE EXTENSION
K915114 · Target Therapeutics · Feb 1992
CORDIS CINCH(R) STEERABLE GUIDEWIRE EXT W/SLX COAT
K914863 · Cordis Corp. · Dec 1991
ONTRAC
K914138 · Lake Region Mfg., Inc. · Dec 1991
REMOVE LABELING RESTRICT FROM GUIDE WIRES
K912293 · Target Therapeutics · Dec 1991