Cleared Traditional

K832607 - OPEN END SPRING GUIDE

K832607 is the FDA 510(k) clearance for OPEN END SPRING GUIDE by C.R. Bard, Inc.. It is a Class 2 Cardiovascular device (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

Submission Details

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.

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 K832607.
BIOPATCH BOVINE PERICARDIAL PATCH
K840756 · Meadox Medicals, Div. Boston Scientific Corp. · Feb 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
GUIDE WIRE
K821190 · Advanced Cardiovascular Systems, Inc. · Aug 1982
CATHETER GUIDE WIRE
K820699 · Quest Medical, Inc. · Apr 1982