Cleared Traditional

K780438 - SAFETY SPRING GUIDES

K780438 is the FDA 510(k) clearance for SAFETY SPRING GUIDES by C.R. Bard, Inc.. It is a Class 2 Cardiovascular device (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

Submission Details

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.

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 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
CARDIOVASCULAR SPRING GUIDES
K770977 · Lake Region Mfg., Inc. · Jun 1977
ANGIOGRAPHIC GUIDEWIRE
K760944 · Medrad, Inc. · Dec 1976