Cleared Traditional

K810508 - SONTEK ANGIOGRAPHIC CATHETER

K810508 is an FDA 510(k) clearance for SONTEK ANGIOGRAPHIC CATHETER, manufactured by Sontek Corp.. The device is a Class 2 Cardiovascular device with product code DQO cleared through the Traditional 510(k) pathway after a 52-day FDA review.

K810508 · Sontek Corp. · Cardiovascular device
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Apr 1981
Decision
52d
Days
Class 2
Risk

K810508 is an FDA 510(k) clearance for the SONTEK ANGIOGRAPHIC CATHETER. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Sontek Corp. (Mchenry, US). The FDA issued a Cleared decision on April 17, 1981 after a review of 52 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 Sontek Corp. devices

FDA 510(k) Submission Details - K810508

510(k) Number K810508 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 1981
Decision Date April 17, 1981
Days to Decision 52 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 125d · This submission: 52d
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 Cardiovascular 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 K810508.
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GANZ CORONARY REPERFUSION CATHETER
K803270 · American Edwards Laboratories · Mar 1981
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K810360 · Electro-Catheter Corp. · Mar 1981
USCI CARDIOVASCULAR CATHETER
K810412 · C.R. Bard, Inc. · Mar 1981