Cleared Traditional

K820516 - ARTERIAL CANALIZATION DEVICE

K820516 is an FDA 510(k) clearance for ARTERIAL CANALIZATION DEVICE, manufactured by Alimed, Inc.. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K820516 · Alimed, Inc. · Cardiovascular device
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Apr 1982
Decision
49d
Days
Class 2
Risk

K820516 is an FDA 510(k) clearance for the ARTERIAL CANALIZATION DEVICE. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Alimed, Inc. (Walker, US). The FDA issued a Cleared decision on April 15, 1982 after a review of 49 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - 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 Alimed, Inc. devices

FDA 510(k) Submission Details - K820516

510(k) Number K820516 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 1982
Decision Date April 15, 1982
Days to Decision 49 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
76d faster than avg
Panel avg: 125d · This submission: 49d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQY Device Classification - Class 2, Special Controls

Product Code DQY Catheter, Percutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
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 - DQY Catheter, Percutaneous

All 761
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K820516.
INTRAOPERATIVE BALLOON DILATION CATH.
K822393 · Advanced Cardiovascular Systems, Inc. · Nov 1982
MULTIPURPOSE CATHETER
K821189 · Advanced Cardiovascular Systems, Inc. · Jul 1982
RIGHT ATRIAL CATHETERS PARENTERAL NUTRIT
K821480 · The Healthcare Group Laboratories, Inc. · Jun 1982
ARROW M.I.S. MULTI-LUMEN CATHETERIZA
K820648 · Arrow Intl., Inc. · Apr 1982
ARROW JUGULAR PUNCTURE KIT 16 GA.
K820009 · Arrow Intl., Inc. · Jan 1982
EDSLAB CATHETER COVER
K813514 · American Edwards Laboratories · Dec 1981