Cleared Traditional

K822806 - BALLOON WEDGE PRESSURE, ANGIOGRAPHIC

K822806 is an FDA 510(k) clearance for BALLOON WEDGE PRESSURE, manufactured by Nova Medical Specialties. The device is a Class 2 Cardiovascular device with product code DYG cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K822806 · Nova Medical Specialties · Cardiovascular device
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Nov 1982
Decision
45d
Days
Class 2
Risk

K822806 is an FDA 510(k) clearance for the BALLOON WEDGE PRESSURE, ANGIOGRAPHIC. Classified as Catheter, Flow Directed (product code DYG), Class II - Special Controls.

Submitted by Nova Medical Specialties (Walker, US). The FDA issued a Cleared decision on November 1, 1982 after a review of 45 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Nova Medical Specialties devices

FDA 510(k) Submission Details - K822806

510(k) Number K822806 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 1982
Decision Date November 01, 1982
Days to Decision 45 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
80d faster than avg
Panel avg: 125d · This submission: 45d
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 K822806.
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
SWAN-GANZ BIPOLAR PACING CATHETER
K822723 · American Edwards Laboratories · Oct 1982
SWAN-GANZ FLOW-DIRECTED THERMODIL. CATH
K822350 · American Edwards Laboratories · Aug 1982
LEONARD PERIPHERAL VENOUS PRESSURE CATH
K821996 · Norton Performance Plastics Corp. · Jul 1982