Cleared Traditional

K970494 - HANNIBAL GUIDEWIRE

K970494 is an FDA 510(k) clearance for HANNIBAL GUIDEWIRE, manufactured by Schneider (Europe) GmbH. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K970494 · Schneider (Europe) GmbH · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1997
Decision
88d
Days
Class 2
Risk

K970494 is an FDA 510(k) clearance for the HANNIBAL GUIDEWIRE. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Schneider (Europe) GmbH (Bülach, CH). The FDA issued a Cleared decision on May 9, 1997 after a review of 88 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 Schneider (Europe) GmbH devices

FDA 510(k) Submission Details - K970494

510(k) Number K970494 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 1997
Decision Date May 09, 1997
Days to Decision 88 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 125d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQX Device Classification - Class 2, Special Controls

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 522
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K970494.
PTCA GUIDEWIRE
K970376 · Lake Region Mfg., Inc. · Jun 1997
CHOICE SUPER SUPPORT PTCA GUIDE WIRE, CHOICE PLUS SUPER SUPPORT PTCA GUIDE WIRE, CHOICE EXCHANGE SUPER SUPPORT PTCA GUID
K964551 · Scimed Life Systems, Inc. · May 1997
LOCKING STYLET 2
K970690 · Cook Pacemaker Corp. · May 1997
SCIMED CHOICE FAMILY OF PTCA GUIDE WIRES
K970244 · Scimed Life Systems, Inc. · Mar 1997
CHOICE PT PLUS PTCA GUIDE WIRE AND CHOICE PT VISION PTCA GUIDE WIRE
K965023 · Scimed Life Systems, Inc. · Mar 1997
CORDIS MARKER WIRE STEERABLE GUIDEWIRE (STABILIZER WITH RADIOPAQUE MARKERS) AND (WIZDOM WITH RADIOPAQUE MARKERS)
K962765 · Cordis Corp. · Feb 1997