Cleared Traditional

K802629 - STERI-SLEEVE

K802629 is an FDA 510(k) clearance for STERI-SLEEVE, manufactured by Cordis Corp.. The device is a Class 2 Cardiovascular device with product code DQO cleared through the Traditional 510(k) pathway after a 8-day FDA review.

K802629 · Cordis Corp. · Cardiovascular device
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Oct 1980
Decision
8d
Days
Class 2
Risk

K802629 is an FDA 510(k) clearance for the STERI-SLEEVE. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Cordis Corp. (Mchenry, US). The FDA issued a Cleared decision on October 31, 1980 after a review of 8 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 Cordis Corp. devices

FDA 510(k) Submission Details - K802629

510(k) Number K802629 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 1980
Decision Date October 31, 1980
Days to Decision 8 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
117d faster than avg
Panel avg: 125d · This submission: 8d
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 320
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K802629.
BAIM TM CORONARY SINUS FLOW THERMAL
K810360 · Electro-Catheter Corp. · Mar 1981
USCI CARDIOVASCULAR CATHETER
K810412 · C.R. Bard, Inc. · Mar 1981
PRESSURE MONITORING SET
K802945 · Norton Performance Plastics Corp. · Dec 1980
PACKAGE FOR MEDI-TRACE PHYSIOLOGICAL PRE
K801321 · Graphic Controls Corp. · Jun 1980
MEDI-TRACE DISP. LINES FOR PHYSIO. PRESS
K801322 · Graphic Controls Corp. · Jun 1980
EXTENSION LINE
K800622 · Norton Performance Plastics Corp. · Apr 1980