Cleared Traditional

K830604 - WEDGE PRESSURE CATHETER

K830604 is the FDA 510(k) clearance for WEDGE PRESSURE CATHETER by Plasmedics, Inc.. It is a Class 2 Cardiovascular device (product code DYG) cleared through the Traditional 510(k) pathway after a 143-day FDA review.

K830604 · Plasmedics, Inc. · Cardiovascular device
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Jul 1983
Decision
143d
Days
Class 2
Risk

K830604 is an FDA 510(k) clearance for the WEDGE PRESSURE CATHETER. Classified as Catheter, Flow Directed (product code DYG), Class II - Special Controls.

Submitted by Plasmedics, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 18, 1983 after a review of 143 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 Plasmedics, Inc. devices

Submission Details

510(k) Number K830604 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 1983
Decision Date July 18, 1983
Days to Decision 143 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
18d slower than avg
Panel avg: 125d · This submission: 143d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 41
Devices cleared under the same product code (DYG) and FDA review panel - the closest regulatory comparables to K830604.
IL HEPARINIZED FLOW DIRECTED THERMAL
K833836 · Instrumentation Laboratory CO · Feb 1984
USCI ANGIOGRAPHIC BALLOON CATHETER
K831854 · C.R. Bard, Inc. · Oct 1983
FLOW-DIRECTED HEPARIN COATED THERMODIL
K832957 · Sorensen Research · Sep 1983
CARDIAC OUTPUT MEASURE SYSTEM
K831185 · Cook, Inc. · May 1983
THERMAL DILUTION CATHETER
K823484 · Instrumentation Laboratory CO · Dec 1982
SWAN-GANZ BIPOLAR PACING CATHETER
K822723 · American Edwards Laboratories · Oct 1982