Cleared Traditional

K882977 - ASK-300

K882977 is the FDA 510(k) clearance for ASK-300 by Medical Repackers Co.. It is a Class 2 Cardiovascular device (product code DQR) cleared through the Traditional 510(k) pathway after a 174-day FDA review.

K882977 · Medical Repackers Co. · Cardiovascular device
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Jan 1989
Decision
174d
Days
Class 2
Risk

K882977 is an FDA 510(k) clearance for the ASK-300. Classified as Cannula, Catheter (product code DQR), Class II - Special Controls.

Submitted by Medical Repackers Co. (Fort Payne, US). The FDA issued a Cleared decision on January 5, 1989 after a review of 174 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1300 - 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 Medical Repackers Co. devices

Submission Details

510(k) Number K882977 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 1988
Decision Date January 05, 1989
Days to Decision 174 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d slower than avg
Panel avg: 125d · This submission: 174d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQR Cannula, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1300
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 - DQR Cannula, Catheter

Devices cleared under the same product code (DQR) and FDA review panel - the closest regulatory comparables to K882977.
ANGIODYNAMICS, INC., MICRO ACCESS KITS
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