Cleared Traditional

K970376 - PTCA GUIDEWIRE

K970376 is an FDA 510(k) clearance for PTCA GUIDEWIRE, manufactured by Lake Region Mfg., Inc.. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Traditional 510(k) pathway after a 123-day FDA review.

K970376 · Lake Region Mfg., Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1997
Decision
123d
Days
Class 2
Risk

K970376 is an FDA 510(k) clearance for the PTCA GUIDEWIRE. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Lake Region Mfg., Inc. (Chaska, US). The FDA issued a Cleared decision on June 6, 1997 after a review of 123 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Lake Region Mfg., Inc. devices

FDA 510(k) Submission Details - K970376

510(k) Number K970376 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 1997
Decision Date June 06, 1997
Days to Decision 123 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
2d faster than avg
Panel avg: 125d · This submission: 123d
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 541
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K970376.
GUGLIELMI DETACHABLE COIL (GDC), FIBERED PLATINUM COIL, .035 TYPE, BERENSTEIN LIQUID COIL, FIBERED PLATINUM COILS, ACCE
K971395 · Target Therapeutics · Jul 1997
ASC BALANCE MIDDLEWEIGHT GUIDE WIRE
K971815 · Guidant Corp. · Jul 1997
TRANSEND EX PLATINUM GUIDEWIRE
K971254 · Boston Scientific Corp · Jul 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