Cleared Traditional

K770569 - CATHETER

K770569 is the FDA 510(k) clearance for CATHETER by Universal Medical Instrument Corp.. It is a Class 2 Cardiovascular device (product code DXE) cleared through the Traditional 510(k) pathway after a 11-day FDA review.

K770569 · Universal Medical Instrument Corp. · Cardiovascular device
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Apr 1977
Decision
11d
Days
Class 2
Risk

K770569 is an FDA 510(k) clearance for the CATHETER, EMBOLECTOMY, UMI. Classified as Catheter, Embolectomy (product code DXE), Class II - Special Controls.

Submitted by Universal Medical Instrument Corp. (Mchenry, US). The FDA issued a Cleared decision on April 5, 1977 after a review of 11 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5150 - 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 Universal Medical Instrument Corp. devices

Submission Details

510(k) Number K770569 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 25, 1977
Decision Date April 05, 1977
Days to Decision 11 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
114d faster than avg
Panel avg: 125d · This submission: 11d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DXE Catheter, Embolectomy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5150
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 - DXE Catheter, Embolectomy

All 36
Devices cleared under the same product code (DXE) and FDA review panel - the closest regulatory comparables to K770569.
EMBOLECTOMY CATHETER, EXTEND. SHELF LIFE
K780762 · Shiley, Inc. · May 1978
CATHETERS, ARTERIAL EMBOLECTOMY
K780244 · Extracorporeal Medical Specialities, Inc. · Apr 1978
CATHETER, ARTERIAL EMBOLECTOMY
K770714 · Mallinckrodt Critical Care · Apr 1977
ELECATH ARTERIAL EMBOLECTOMY CATHETER
K761031 · Electro-Catheter Corp. · Dec 1976