Cleared Traditional

K821189 - MULTIPURPOSE CATHETER

K821189 is the FDA 510(k) clearance for MULTIPURPOSE CATHETER by Advanced Cardiovascular Systems, Inc.. It is a Class 2 Cardiovascular device (product code DQY) cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K821189 · Advanced Cardiovascular Systems, Inc. · Cardiovascular device
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Jul 1982
Decision
72d
Days
Class 2
Risk

K821189 is an FDA 510(k) clearance for the MULTIPURPOSE CATHETER. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Advanced Cardiovascular Systems, Inc. (Santa Clara, US). The FDA issued a Cleared decision on July 8, 1982 after a review of 72 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 Advanced Cardiovascular Systems, Inc. devices

Submission Details

510(k) Number K821189 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 1982
Decision Date July 08, 1982
Days to Decision 72 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
53d faster than avg
Panel avg: 125d · This submission: 72d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 588
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K821189.
CORONARY GUIDING CATHETER-MODIFIED
K831563 · Advanced Cardiovascular Systems, Inc. · Jun 1983
CORONARY INFUSION CATHETER
K831717 · Advanced Cardiovascular Systems, Inc. · Jun 1983
INTRAOPERATIVE BALLOON DILATION CATH.
K822393 · Advanced Cardiovascular Systems, Inc. · Nov 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