Cleared Traditional

K780438 - SAFETY SPRING GUIDES, TEFLON COATED

K780438 is an FDA 510(k) clearance for SAFETY SPRING GUIDES, manufactured by C.R. Bard, Inc.. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Traditional 510(k) pathway after a 100-day FDA review.

K780438 · C.R. Bard, Inc. · Cardiovascular device
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Jun 1978
Decision
100d
Days
Class 2
Risk

K780438 is an FDA 510(k) clearance for the SAFETY SPRING GUIDES, TEFLON COATED. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 28, 1978 after a review of 100 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 C.R. Bard, Inc. devices

FDA 510(k) Submission Details - K780438

510(k) Number K780438 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 1978
Decision Date June 28, 1978
Days to Decision 100 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
25d faster than avg
Panel avg: 125d · This submission: 100d
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 681
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K780438.
PERVENOUS LEAD INTRODUCER SYSTEM
K791276 · Cordis Corp. · Jul 1979
MOVABLE CORE SAFETY GUIDE
K790258 · Cordis Corp. · Feb 1979
VARIABLE STIFFNESS WIRE GUIDE
K781393 · Cook, Inc. · Oct 1978
ELECATH PLASTIC JACKETED GUIDEWIRE
K780493 · Electro-Catheter Corp. · Apr 1978
CARDIOVASCULAR SPRING GUIDES
K770977 · Lake Region Mfg., Inc. · Jun 1977
ANGIOGRAPHIC GUIDEWIRE
K760944 · Medrad, Inc. · Dec 1976