Cleared Traditional

K822393 - INTRAOPERATIVE BALLOON DILATION CATH.

K822393 is the FDA 510(k) clearance for INTRAOPERATIVE BALLOON DILATION CATH. by Advanced Cardiovascular Systems, Inc.. It is a Class 2 Cardiovascular device (product code DQY) cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K822393 · Advanced Cardiovascular Systems, Inc. · Cardiovascular device
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Nov 1982
Decision
84d
Days
Class 2
Risk

K822393 is an FDA 510(k) clearance for the INTRAOPERATIVE BALLOON DILATION CATH.. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Advanced Cardiovascular Systems, Inc. (Walker, US). The FDA issued a Cleared decision on November 1, 1982 after a review of 84 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 K822393 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 1982
Decision Date November 01, 1982
Days to Decision 84 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
41d faster than avg
Panel avg: 125d · This submission: 84d
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 K822393.
CATHETER INSERTION TRAYS, VARIOUS #'S
K831807 · American Pharmaseal Div. Ahsc · Jul 1983
CORONARY GUIDING CATHETER-MODIFIED
K831563 · Advanced Cardiovascular Systems, Inc. · Jun 1983
CORONARY INFUSION CATHETER
K831717 · Advanced Cardiovascular Systems, Inc. · Jun 1983
MULTIPURPOSE CATHETER
K821189 · Advanced Cardiovascular Systems, Inc. · Jul 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