Cleared Traditional

K942927 - 0.035 IN. WISE WIRE

K942927 is an FDA 510(k) clearance for 0.035 IN. WISE WIRE, manufactured by Boston Scientific Corp. The device is a Class 2 Radiology device with product code DQO cleared through the Traditional 510(k) pathway after a 356-day FDA review.

K942927 · Boston Scientific Corp · Radiology device
Download Printable Device Report (PDF)
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Jun 1995
Decision
356d
Days
Class 2
Risk

K942927 is an FDA 510(k) clearance for the 0.035 IN. WISE WIRE. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Boston Scientific Corp (Watertown, US). The FDA issued a Cleared decision on June 13, 1995 after a review of 356 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 870.1200 - the FDA radiology and imaging software 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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Boston Scientific Corp devices

FDA 510(k) Submission Details - K942927

510(k) Number K942927 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 1994
Decision Date June 13, 1995
Days to Decision 356 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
249d slower than avg
Panel avg: 107d · This submission: 356d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQO Device Classification - Class 2, Special Controls

Product Code DQO Catheter, Intravascular, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1200
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 Radiology devices follow this clearance model.

Regulatory Peers - DQO Catheter, Intravascular, Diagnostic

All 391
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K942927.
BRAUN SELECTIVE ANGIOGRAPHIC CATHETER
K950882 · B.Braun Medical, Inc. · Aug 1995
TRANSIT-2 INFUSION CATHETER
K950910 · Cordis Neurovascular, Inc. · Aug 1995
SCIMED EXPO ANGIOGRAPHIC CATHETER
K951720 · Scimed Life Systems, Inc. · Jun 1995
TRANSIT-2 INFUSION CATHETER
K950909 · Cordis Neurovascular, Inc. · May 1995
SCIMED 6 FRENCH EXPO ANGIOGRAPHIC CATHETER
K950731 · Scimed Life Systems, Inc. · Apr 1995
CONTROL
K944284 · Daig Corp. · Mar 1995