Cleared Traditional

K832380 - PROTECTIVE SLEEVE

K832380 is an FDA 510(k) clearance for PROTECTIVE SLEEVE, manufactured by Vertex Medical Corp.. The device is a Class 2 Cardiovascular device with product code DYG cleared through the Traditional 510(k) pathway after a 132-day FDA review.

K832380 · Vertex Medical Corp. · Cardiovascular device
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Nov 1983
Decision
132d
Days
Class 2
Risk

K832380 is an FDA 510(k) clearance for the PROTECTIVE SLEEVE. Classified as Catheter, Flow Directed (product code DYG), Class II - Special Controls.

Submitted by Vertex Medical Corp. (Mchenry, US). The FDA issued a Cleared decision on November 28, 1983 after a review of 132 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1240 - 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 Vertex Medical Corp. devices

FDA 510(k) Submission Details - K832380

510(k) Number K832380 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 1983
Decision Date November 28, 1983
Days to Decision 132 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
7d slower than avg
Panel avg: 125d · This submission: 132d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DYG Device Classification - Class 2, Special Controls

Product Code DYG Catheter, Flow Directed
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1240
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 - DYG Catheter, Flow Directed

All 69
Devices cleared under the same product code (DYG) and FDA review panel - the closest regulatory comparables to K832380.
IL HEPARINIZED FLOW DIRECTED THERMAL
K833836 · Instrumentation Laboratory CO · Feb 1984
HEPARIN-COATED BALLOON THERMODILUT
K833572 · Critikon Company, LLC · Jan 1984
INFUSION PORT BALLOON THERMODILUTION
K833918 · Critikon Company, LLC · Jan 1984
USCI ANGIOGRAPHIC BALLOON CATHETER
K831854 · C.R. Bard, Inc. · Oct 1983
FLOW-DIRECTED HEPARIN COATED THERMODIL
K832957 · Sorensen Research · Sep 1983
ELECATH BALTHERM TLC THERMAL DILUTION
K831945 · Electro-Catheter Corp. · Aug 1983