Cleared Traditional

K780529 - MYOCATH KIT

K780529 is the FDA 510(k) clearance for MYOCATH KIT by Sorensen Research. It is a Class 2 Cardiovascular device (product code DQO) cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K780529 · Sorensen Research · Cardiovascular device
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May 1978
Decision
36d
Days
Class 2
Risk

K780529 is an FDA 510(k) clearance for the MYOCATH KIT. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Sorensen Research (Mchenry, US). The FDA issued a Cleared decision on May 9, 1978 after a review of 36 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1200 - 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 Sorensen Research devices

Submission Details

510(k) Number K780529 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 1978
Decision Date May 09, 1978
Days to Decision 36 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
89d faster than avg
Panel avg: 125d · This submission: 36d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 Cardiovascular devices follow this clearance model.

Regulatory Peers - DQO Catheter, Intravascular, Diagnostic

All 234
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K780529.
POST EXTRA SYSTOLIC POTENTIATOR
K781819 · Medrad, Inc. · Jan 1979
CATHETER, DIGITAL POSITRAL II
K782082 · C.R. Bard, Inc. · Dec 1978
PRESSURE MONITORING INJECTION LINES
K781558 · Cobe Laboratories, Inc. · Oct 1978
CATHETER, POLYURETHANE, W/STYLET
K770868 · Abbott Laboratories · Jun 1977
PUNCTURE KIT, INTERNAL JUGULAR
K770462 · Arrow Intl., Inc. · Mar 1977