Cleared Traditional

K882977 - ASK-300

K882977 is an FDA 510(k) clearance for ASK-300, manufactured by Medical Repackers Co.. The device is a Class 2 Cardiovascular device with 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

FDA 510(k) Submission Details - K882977

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.

DQR Device Classification - Class 2, Special Controls

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

All 20
Devices cleared under the same product code (DQR) and FDA review panel - the closest regulatory comparables to K882977.
RMI ARTERIAL PERFUSION CANNULA
K894243 · Research Medical, Inc. · Sep 1989
DAIG COLLAPSIBLE STERILE SLEEVE
K884478 · Daig Corp. · Feb 1989
TRANSLUMBAR AORTOGRAPHY NEEDLE CATHETER
K884375 · Argon Medical Corp. · Jan 1989
MEDSURG 7 FR. DUAL LUMEN CENTRAL VEIN CATH SYSTEM
K880771 · Medsurg Industries, Inc. · May 1988
7 FR. TRIPLE LUMEN CENTRAL VEIN CATHETERI. SYSTEM
K880776 · Medsurg Industries, Inc. · May 1988
BAXTER ACCUPORT(TM) CENTRAL VENOUS CATHETER
K874618 · Bentley Laboratories, Inc. · Jan 1988