Cleared Traditional

K833676 - SURGICAL VESSEL DILATORS-CATHERIZA-

K833676 is an FDA 510(k) clearance for SURGICAL VESSEL DILATORS-CATHERIZA-, manufactured by Cimed Intl., Inc.. The device is a Class 2 Cardiovascular device with product code DWP cleared through the Traditional 510(k) pathway after a 157-day FDA review.

K833676 · Cimed Intl., Inc. · Cardiovascular device
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Mar 1984
Decision
157d
Days
Class 2
Risk

K833676 is an FDA 510(k) clearance for the SURGICAL VESSEL DILATORS-CATHERIZA-. Classified as Dilator, Vessel, Surgical (product code DWP), Class II - Special Controls.

Submitted by Cimed Intl., Inc. (Mchenry, US). The FDA issued a Cleared decision on March 19, 1984 after a review of 157 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4475 - 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 Cimed Intl., Inc. devices

FDA 510(k) Submission Details - K833676

510(k) Number K833676 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 1983
Decision Date March 19, 1984
Days to Decision 157 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d slower than avg
Panel avg: 125d · This submission: 157d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DWP Device Classification - Class 2, Special Controls

Product Code DWP Dilator, Vessel, Surgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4475
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 - DWP Dilator, Vessel, Surgical

All 17
Devices cleared under the same product code (DWP) and FDA review panel - the closest regulatory comparables to K833676.
FLO-RESTER(R) VESSEL SIZER
K905159 · Bio-Vascular, Inc. · Feb 1991
FOGARTY VESSEL CALIBRATOR
K902143 · Baxter Healthcare Corp · Oct 1990
PTI INTRA-ART(R) CORONARY ARTERY PROBE (STERILE)
K891786 · Pioneering Technologies, Inc. · Oct 1989
VESSEL DILATOR
K832595 · Abbott Laboratories · Aug 1983
REUSABLE FOGARTY FLEXIBLE CALIBRATOR
K822687 · American Edwards Laboratories · Oct 1982
FOGARTY FLEXIBLE PROBE
K812935 · American Edwards Laboratories · Nov 1981