Cleared Traditional

K832607 - OPEN END SPRING GUIDE

K832607 is an FDA 510(k) clearance for OPEN END SPRING GUIDE, 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 146-day FDA review.

K832607 · C.R. Bard, Inc. · Cardiovascular device
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Dec 1983
Decision
146d
Days
Class 2
Risk

K832607 is an FDA 510(k) clearance for the OPEN END SPRING GUIDE. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Warrendale, US). The FDA issued a Cleared decision on December 27, 1983 after a review of 146 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 - K832607

510(k) Number K832607 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 1983
Decision Date December 27, 1983
Days to Decision 146 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
21d slower than avg
Panel avg: 125d · This submission: 146d
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 K832607.
HYDROGLIDE SPRING GUIDE WIRES
K841926 · Argon Medical Corp. · Jan 1985
WIREGUIDE OR GUIDEWIRE
K843012 · Medi-Tech, Inc. · Nov 1984
CARDIOVASCULAR SPRING GUIDE WIRE
K834223 · Mallinckrodt Critical Care · Feb 1984
STAINLESS STEEL GUIDE WIRE
K831839 · Quinton, Inc. · Jul 1983
TEFLON COATED GUIDE WIRES & CATHETER
K822586 · Universal Medical Instrument Corp. · Oct 1982
GUIDE WIRE
K822597 · Vertex Medical Corp. · Sep 1982