Cleared Traditional

K821188 - INTRODUCER SET

K821188 is an FDA 510(k) clearance for INTRODUCER SET, manufactured by Advanced Cardiovascular Systems, Inc.. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K821188 · Advanced Cardiovascular Systems, Inc. · Cardiovascular device
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Jul 1982
Decision
72d
Days
Class 2
Risk

K821188 is an FDA 510(k) clearance for the INTRODUCER SET. Classified as Introducer, Catheter (product code DYB), 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 870.1340 - 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

FDA 510(k) Submission Details - K821188

510(k) Number K821188 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.

DYB Device Classification - Class 2, Special Controls

Product Code DYB Introducer, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1340
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 - DYB Introducer, Catheter

All 604
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K821188.
PERCUTANEOUS CATHETER INTRODUCER SET
K822593 · Vertex Medical Corp. · Sep 1982
CATH-SEAL
K822247 · Universal Medical Instrument Corp. · Aug 1982
ARGYLE INTRAMEDICUT CATHETER KIT
K821324 · Sherwood Medical Co. · Jul 1982
PERCOR PERCUTANEOUS INTRODUCER
K820834 · Datascope Corp. · Apr 1982
NEONATAL INTRODUCER KIT
K820710 · Norton Performance Plastics Corp. · Apr 1982
NORTON JUGULAR KITS
K820581 · Norton Performance Plastics Corp. · Mar 1982