Cleared Traditional

K830604 - WEDGE PRESSURE CATHETER

K830604 is an FDA 510(k) clearance for WEDGE PRESSURE CATHETER, manufactured by Plasmedics, Inc.. The device is a Class 2 Cardiovascular device with 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

FDA 510(k) Submission Details - K830604

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.

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 72
Devices cleared under the same product code (DYG) and FDA review panel - the closest regulatory comparables to K830604.
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
CARDIAC OUTPUT MEASURE SYSTEM
K831185 · Cook, Inc. · May 1983
THERMAL DILUTION CATHETER
K823484 · Instrumentation Laboratory CO · Dec 1982
BALLOON THERMODILUTION CATHETER #7164&
K823433 · Critikon Company, LLC · Nov 1982