Cleared Traditional

K772175 - CATHETER SYSTEM, COPE/EISENBERG

K772175 is an FDA 510(k) clearance for CATHETER SYSTEM, manufactured by Victory Engineering Corp.. The device is a Class 2 Radiology device with product code DQO cleared through the Traditional 510(k) pathway after a 7-day FDA review.

K772175 · Victory Engineering Corp. · Radiology device
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Nov 1977
Decision
7d
Days
Class 2
Risk

K772175 is an FDA 510(k) clearance for the CATHETER SYSTEM, COPE/EISENBERG. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Victory Engineering Corp. (Mchenry, US). The FDA issued a Cleared decision on November 28, 1977 after a review of 7 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 870.1200 - the FDA radiology and imaging software 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 Victory Engineering Corp. devices

FDA 510(k) Submission Details - K772175

510(k) Number K772175 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 1977
Decision Date November 28, 1977
Days to Decision 7 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
100d faster than avg
Panel avg: 107d · This submission: 7d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQO Device Classification - Class 2, Special Controls

Product Code DQO Catheter, Intravascular, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1200
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 Radiology devices follow this clearance model.

Regulatory Peers - DQO Catheter, Intravascular, Diagnostic

All 423
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K772175.
CATHETER, DIGITAL POSITRAL II
K782082 · C.R. Bard, Inc. · Dec 1978
PRESSURE MONITORING INJECTION LINES
K781558 · Cobe Laboratories, Inc. · Oct 1978
MYOCATH KIT
K780529 · Sorensen Research · May 1978
PRESSURE TUBING
K771810 · Pharmaseal Div., Baxter Healthcare Corp. · Nov 1977
CATHETER, POLYURETHANE, W/STYLET
K770868 · Abbott Laboratories · Jun 1977
MONITORING KIT, CENTRAL VENOUS PRESSURE
K770290 · Argon Medical Corp. · Mar 1977