Cleared Traditional

K870664 - GUIDE WIRE

K870664 is the FDA 510(k) clearance for GUIDE WIRE by Datascope Corp.. It is a Class 2 Cardiovascular device (product code DQX) cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K870664 · Datascope Corp. · Cardiovascular device
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Mar 1987
Decision
34d
Days
Class 2
Risk

K870664 is an FDA 510(k) clearance for the GUIDE WIRE. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Datascope Corp. (Oakland, US). The FDA issued a Cleared decision on March 25, 1987 after a review of 34 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 Datascope Corp. devices

Submission Details

510(k) Number K870664 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 1987
Decision Date March 25, 1987
Days to Decision 34 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
91d faster than avg
Panel avg: 125d · This submission: 34d
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 454
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K870664.
OLYMPUS PF-25 ULTRATHIN ANGIOSCOPE
K871517 · Olympus Corp. · Nov 1987
ACS HI-TORQUE FLEX-T GUIDE WIRE (MODIFICATION)
K872220 · Advanced Cardiovascular Systems, Inc. · Aug 1987
MINISTIK MINI PUNCTURE SET CATALOG CODE #57505
K871137 · Dlp, Inc. · Jul 1987
TARGET THERAPEUTICS TAPER GUIDE WIRE
K864316 · Target Therapeutics · Mar 1987
SCHNEIDER-SHILEY GUIDE WIRE
K864787 · Shiley, Inc. · Feb 1987
ACS HI-TORQUE FLOPPY GUIDE WIRE, 0.018 INCH
K864585 · Advanced Cardiovascular Systems, Inc. · Dec 1986