Cleared Traditional

K910339 - AVD INTIMAX OCCLUSION CATHETER

K910339 is an FDA 510(k) clearance for AVD INTIMAX OCCLUSION CATHETER, manufactured by Applied Vascular Devices, Inc.. The device is a Class 2 Cardiovascular device with product code DQT cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K910339 · Applied Vascular Devices, Inc. · Cardiovascular device
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May 1991
Decision
121d
Days
Class 2
Risk

K910339 is an FDA 510(k) clearance for the AVD INTIMAX OCCLUSION CATHETER. Classified as Occluder, Catheter Tip (product code DQT), Class II - Special Controls.

Submitted by Applied Vascular Devices, Inc. (Laguna Hills, US). The FDA issued a Cleared decision on May 29, 1991 after a review of 121 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1370 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Applied Vascular Devices, Inc. devices

FDA 510(k) Submission Details - K910339

510(k) Number K910339 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 28, 1991
Decision Date May 29, 1991
Days to Decision 121 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
4d faster than avg
Panel avg: 125d · This submission: 121d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQT Device Classification - Class 2, Special Controls

Product Code DQT Occluder, Catheter Tip
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1370
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 - DQT Occluder, Catheter Tip

Devices cleared under the same product code (DQT) and FDA review panel - the closest regulatory comparables to K910339.
GT1 FLOPPY, GT1 HI-PER FLEX, GT1 LIGHT SUPPORT
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K840795 · Advanced Cardiovascular Systems, Inc. · Jul 1984