Cleared Traditional

K922302 - JAGWIRE(TM) RECANALIZATION GUIDEWIRE

K922302 is the FDA 510(k) clearance for JAGWIRE(TM) RECANALIZATION GUIDEWIRE by Boston Scientific Corp. It is a Class 2 Cardiovascular device (product code DQX) cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K922302 · Boston Scientific Corp · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1992
Decision
70d
Days
Class 2
Risk

K922302 is an FDA 510(k) clearance for the JAGWIRE(TM) RECANALIZATION GUIDEWIRE. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Boston Scientific Corp (San Jose, US). The FDA issued a Cleared decision on July 24, 1992 after a review of 70 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 Boston Scientific Corp devices

Submission Details

510(k) Number K922302 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 1992
Decision Date July 24, 1992
Days to Decision 70 days
Submission Type Traditional
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
55d faster than avg
Panel avg: 125d · This submission: 70d
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 498
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K922302.
ROADRUNNER RLTF GUIDE WIRE
K920824 · Cook, Inc. · Oct 1992
BAXTER SENSOR CORONARY GUIDEWIRE
K923240 · Baxter Healthcare Corp · Sep 1992
MERI-DAPT(TM) HEMOSTASIS VALVE/TORQLOC TORQUE DEVI
K921702 · Merit Medical Systems, Inc. · Sep 1992
SCIMED AVENUE CORONARY GUIDEWIRE INSERTION TOOL
K922410 · Scimed Life Systems, Inc. · Jul 1992
SCIMED(R) CONTROLWIRE(TM) GUIDE WIRE
K914194 · Scimed Life Systems, Inc. · Jun 1992
.10' HI-TORQUE FLOPPY, INTER. & STAND. GUIDE WIRE
K915723 · Advanced Cardiovascular Systems, Inc. · Jun 1992