Cleared Traditional

K871425 - ACS ENHANCED-TORQUE CORONARY GUIDING CA...

K871425 is the FDA 510(k) clearance for ACS ENHANCED-TORQUE CORONARY GUIDING CA... by Advanced Cardiovascular Systems, Inc.. It is a Class 2 Cardiovascular device (product code DQY) cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K871425 · Advanced Cardiovascular Systems, Inc. · Cardiovascular device
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May 1987
Decision
44d
Days
Class 2
Risk

K871425 is an FDA 510(k) clearance for the ACS ENHANCED-TORQUE CORONARY GUIDING CATHETER. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Advanced Cardiovascular Systems, Inc. (Mountain View, US). The FDA issued a Cleared decision on May 22, 1987 after a review of 44 days - a notably fast clearance cycle.

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: 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 K871425 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 1987
Decision Date May 22, 1987
Days to Decision 44 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
81d faster than avg
Panel avg: 125d · This submission: 44d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 588
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K871425.
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SUBCLAVIAN, GISH MODEL NO. SVAC-XXXX
K863791 · Gish Biomedical, Inc. · Jun 1987
J-CATH, GISH MODEL NO. JVAC-XXXX
K863790 · Gish Biomedical, Inc. · Jun 1987
MULTICATH - CODE#S 8.1207.OO/8.1208.00/8.1205.20
K870067 · Vygon Corp. · Apr 1987
CENTRAL VENOUS CATHETER
K870075 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1987
MEDI-TECH SELECTIVE TORQUE CATHETER
K864118 · Medi-Tech, Inc. · Apr 1987